TYLENOL®is safe and effective when used as directed. The safety of TYLENOL® at recommended doses has been established through 50 years of use and scientific investigation. Do not exceed the recommended dosage as it may cause liver damage.
Acetaminophen is an active ingredient in all TYLENOL® products and in more than 600 other over-the-counter (OTC) and prescription medicines. Do not take more than one medicine containing acetaminophen at the same time.
TYLENOL® contains the active ingredient acetaminophen, which is a pain reliever and fever reducer. It works by elevating the body's overall pain threshold so you feel less pain, and lowers your fever by helping your body eliminate excess heat.
We continue to experience high consumer demand driven by an extremely challenging cold & flu season. While products may be less readily available at some stores, we are not experiencing widespread shortages of Children’s TYLENOL®. We recognize this may be challenging for parents and caregivers, and are doing everything we can to make sure people have access to the products they need, including maximizing our production capacity, running our sites 24 hours a day, 7 days a week, and continuously shipping out product. We will continue to partner with retailers to provide these products to consumers.
A fever is the body’s response to a disease characterized by a rise in body temperature. A rectal temperature at or above 100.4⁰F, an oral temperature at or above 99.4⁰F, or an axillary temperature at or above 99⁰F is usually considered the threshold for a fever.
Acetaminophen is an effective pain reliever and fever reducer. Acetaminophen is thought to relieve mild to moderate pain by elevating your body’s overall pain threshold. It is also thought to lower your fever by helping your body eliminate excess heat.
Phenylephrine is a nasal decongestant indicated to help clear nasal passages, promote nasal and sinus drainage, and for temporary relief of sinus congestion and pressure.
In September, 2023, The Nonprescription Drugs Advisory Committee of the Food and Drug Administration reviewed efficacy data available for orally administered phenylephrine (PE) as a nasal decongestant. Read the FDA’s statement about this review here.
Both TYLENOL® Cold & Flu Severe and TYLENOL® Cold & Flu and TYLENOL® Cold Multi-Symptom products contain acetaminophen, dextromethorphan, and phenylephrine. Therefore, both products can be used to temporarily reduce fever and are also indicated for the temporary relief of minor aches and pains, headache, sore throat, nasal congestion, cough, sinus congestion, and sinus pressure. Additionally, TYLENOL® Cold & Flu Severe products contain guaifenesin, an expectorant, which helps to relieve chest congestion and clear out mucus.
Easy-to-swallow caplets are solid capsule-shaped tablets coated with a water-soluble coating. Gelcaps are solid capsule-shaped tablets coated with smooth gelatin, making them easier to swallow. Geltabs are solid, rounded tablets coated with smooth gelatin.
Acetaminophen is the active ingredient in TYLENOL®. TYLENOL® products do not contain aspirin, ibuprofen or naproxen, the active ingredients found in other nonprescription pain relievers. Each of these active ingredients relieves pain, but they work differently.
Learn more about active ingredients by comparing pain relievers here.
The main reason is to simplify the dosing of Children’s TYLENOL® for caregivers. The product concentration or strength will now be the same whether you choose Children’s TYLENOL® Liquids or Children’s TYLENOL® Chewables. With the 160 mg product Children will need to take fewer tablets per dose than with the 80 mg product which should improve ease of dosing, especially for older children, who are more likely to use the Children’s TYLENOL® Chewables.
Please check the expiration date of the product you have. If the product has expired please discard it appropriately. If the product is not expired, it can still be used; please read and follow the label instructions.
Unless instructed otherwise, do not dispose of unused medicines by emptying them into your sink, toilet, or storm drain. Some states may have regulations regarding pharmacy or community take-back programs in which they may receive and dispose of returned unused drugs for patients. It is recommended that a local pharmacy or local authority be contacted to determine if it participates in such programs.
In the event that take-back programs cannot dispose medicines, place them in the household trash taking the following steps.
1. Make sure that they are in an unrecognizable sealed container; ensuring that children, pets, and others do not have access to the contents of the container.
2. Dispose of the container in household trash.
Please always read and follow the label. Check the expiration date on the bottle. Unexpired product is safe to use according to the label instructions. Any medication that is beyond its expiration date should be discarded.
Children’s TYLENOL® Suspension (Liquid) and Children’s TYLENOL® Chewables differ by dosage form and by available flavors. Both products are safe and effective for use in children ages 2-11 years when used as directed and provide the same doses of acetaminophen when used according to the label.
This is personal preference, or as directed by your healthcare professional. Both the Children’s TYLENOL® Suspension and the Children’s TYLENOL® Chewables are safe and effective for children ages 2-11 years when used as directed.
The Children’s TYLENOL® Chewables Grape and Bubblegum products both have a score, or a “break” line, to indicate the ½ tablet for dosing. Breaking the product in half to achieve the appropriate dose can be done using that score line. Some consumers may use a pill splitter to divide the tablet cleanly along the score line, but Children’s TYLENOL® Chewables should break along the score line just by using your fingers.
The Children’s TYLENOL® Chewables product has a score, or a “break line,” that assists in accurately splitting a tablet in half. You can use your fingers to break the tablet along the line, or if desired, you may use a tool such as a pill cutter to help break the tablet in half.
Children’s TYLENOL® Chewables is only being sold in 160 mg strength. The lowest labeled dose for Children’s TYLENOL® Chewables has always been 160 mg (which is equivalent to two 80 mg tablets). If your child is under two years or under 24 pounds, please ask your doctor to recommend an appropriate product and dose.
The Children’s TYLENOL® Chewables are appropriate for most children aged 2-11 years. A half tablet of the 160 mg Children’s TYLENOL® Chewable tablet is equivalent to 80 mg. Please always read and follow the label to determine the correct dosing for your child.
This is personal preference, or as directed by your healthcare professional. Both the Children’s TYLENOL® Suspension and the Children’s TYLENOL® Chewables are appropriate for most children ages 2-11 years.
In the lower left of the carton and on the label, the packaging will state the 160 mg strength. Children’s TYLENOL® Chewables includes the brand name “Children’s TYLENOL® Chewables” on the package and is only sold in 160 mg strength. The Children’s TYLENOL® Chewables 160 mg Bubblegum tablets are pink and the Grape tablets are purple. Both are identified by the marking/ imprint on the tablet that says “TY 160” on one side and the word “Half” marked twice on the other side. We recommend that you always keep the tablets in their original containers (bottles) for ready access to the dosing directions and expiration date and to avoid unintended access.
Please check the expiration dates on the bottles. You may continue to use the product as long as it has not expired. Please keep the products in their original bottles—do not combine 2 strengths in one container.
You should always use only one acetaminophen-containing medicine at a time. Always read and follow the label when administering any medicine to your child. Ask your doctor if you have further questions regarding appropriate dosing for your child.
Opioids are a class of prescription medications used to treat acute, severe pain. The active ingredient in all over-the-counter single ingredient, TYLENOL® products is acetaminophen. Acetaminophen is not an opioid.
Yes, if you schedule your doses correctly and take no more than 5 total doses in 24 hours. These products are to be used if you have symptoms. TYLENOL® Daytime products provide daytime relief for your cold and flu symptoms. Do not take TYLENOL® Daytime and Nighttime products at the same time and only use products that treat the symptom you have. Always use TYLENOL® products as directed and read the entire product label before using.
Only TYLENOL® Cold Multi-Symptom Liquid (Nighttime) contains doxylamine succinate, an antihistamine, which may cause marked drowsiness. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. Alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Always use the product as directed and read the label.
The package label of all OTC pain medicines advise consumers to "stop use and ask a doctor if … pain gets worse or lasts more than 10 days…" This warning is necessary so that patients will seek appropriate medical attention if needed.
The safety of TYLENOL® at recommended doses has been established through 50 years of use and scientific investigation; however, if you take too much, you could harm your liver.
In case of overdose, consumers are instructed to get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if no signs or symptoms are noticed.
If you are taking any other drugs, including herbal supplements, you should talk to your doctor or pharmacist if you want to know more or have other questions. Always use the product as directed and read the label.
Sinus headaches are usually characterized by a throbbing pain in your forehead or behind your eyes that may increase when you lean forward or lie down. You may also experience pressure between your eyes or tenderness in your cheekbones, a sore throat, runny nose or cough. These symptoms may be a result of your nasal passages becoming swollen due to environmental irritants, allergies, or even a cold. As cold and flu symptoms can be very similar, please refer to the following differences:
A cold is characterized by a runny nose, watery eyes, stuffy nose, and congestion, sneezing and coughing. These symptoms build over 48 hours and may last for 3-10 days. Unlike the cold, flu symptoms such as fever and chills appear very quickly and may last for 7-14 days (and may linger for up to 3 weeks). Other symptoms include body aches and pains, weakness and fatigue.
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