FDA Label for Childrens Pain Relief

Active Ingredient (In Each Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

• •temporarily relieves minor aches and pains due to:
  • •the common cold
  • •flu
  • •headache
  • •sore throat
  • •toothache
  • •temporarily reduces fever
  
  

Warnings

Liver warning:  This product contains acetaminophen. Severe liver damage may occur if your child takes:

• •more than 5 doses in 24 hours, which is the maximum daily amount
• •with other drugs containing acetaminophen.

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

• •skin reddening
• •blisters
• •rash

If a skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Do Not Use

• •with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• •if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has

liver disease.

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin.

When Using This Product

do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

• •pain gets worse or lasts more than 5 days
• •fever gets worse or lasts more than 3 days
• •new symptoms occur
• •redness or swelling is present

These could be signs of a serious condition.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

• •this product does not contain directions or complete warnings for adult use.
• •do not give more than directed (see overdose warning)
• •find the right dose on chart below. If possible, use weight to dose; otherwise use age.
• •chew before swallowing
• •if needed, repeat dose every 4 hours while symptoms last
• •do not give more than 5 times in 24 hours

Weight (lbs)	under 24	24-35	36-47	48-59	60-71	72-95
Age (yrs)	under 2 years	2-3- years	4-5 years	6-8 years	9-10 years	11 years
Dose(tablets)*	ask a doctor	1	1 1/2	2	2 1/2	3

•  *or as directed by a doctor

Other Information

• •store at room temperature Avoid high humidity.
• •see end flap for expiration date and lot number
• •keep this carton for future reference on full labeling

Inactive Ingredients

citric acid, crospovidone, dextrose, flavor, magnesium stearate, maltodextrin, starch, sucralose

Questions Or Comments?

1-866-467-2748

Principal Display Panel

NDC 69842-160-24

Compare to the active ingredient in Children’s Tylenol^® Chewables†

Children’s

Pain Relief

Acetaminophen 160 mg

Pain reliever/Fever reducer

Ages 2-11

Free of: Aspirin & Ibuprofen

BUBBLEGUM FLAVOR

24 CHEWABLE TABLETS

160 mg each

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children’s Tylenol^® Chewables.

Distributed by: CVS Pharmacy, Inc,

One CVS Drive, Woonsocket, RI 02895

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CVS Health Children's Pain Relief Acetaminophen 160mg 24 Chewable Tablets - 160GR24PVFC