FDA Label for Acetaminophen

Drug Facts

Active ingredient (in each chewable tablet)

Acetaminophen USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • soar 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

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: In case of overdose, 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 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)
• chew or crush tablets completely before swallowing; do not swallow tablets whole
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets)*
under 24	under 2 years	ask a doctor
24 to 35 lbs	2 to 3 years	1 tablet
36 to 47 lbs	4 to 5 years	1½ tablets
48 to 59 lbs	6 to 8 years	2 tablets
60 to 71 lbs	9 to 10 years	2½ tablets
72 to 95 lbs	11 years	3 tablets

* or as directed by a doctor

Other Information

• store between 20° to 25°C (68° to 77°F). Avoid high humidity. Protect from light.
• do not use if carton is open or if printed seal on blister is broken or missing.

Inactive Ingredients

citric acid anhydrous, colloidal silicon dioxide, copovidone, crospovidone, D&C red No.27 lake, D&C red 30 aluminum lake, dextrose monohydrate, ethylcellulose, flavor, magnesium stearate, mannitol, sodium starch glycolate, stearic acid, sucralose.

Questions Or Comments?

Call 1-855-274-4122

Package Label-Principal Display Panel 160 Mg (48 Chewable Tablets Blister Carton Label)

Healthy Living^TM
Ages 2-11               DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

CHILDREN’S PAIN RELIEF
acetaminophen chewable tablets 160 mg

Pain Reliever / Fever Reducer

160 mg
per Tablet

Pain + Fever

Chewables - Chew or crush
tablets completely before swallowing

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

• Aspirin Free              
• Ibuprofen Free

Bubble Gum Flavor                            Actual Size
                                                   48 Chewable Tablets
                                                      160 mg each

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 160 mg (24 Chewable Tablets Bottle Carton Label) - acetaminophen fig1