FDA Label for Childrens Acetaminophen Oral Suspension

Active Ingredient

(in each 5 mL)
Acetaminophen 160 mg

Purpose

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses Temporarily:

• reduces fever
• minor aches and pains due to:

• the common cold • flu • headache • sore throat • toothache

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 non-prescription). 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

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease.

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

Otc - When Using

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.

Otc - Keep Out Of Reach Of Children

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 children even if you do not notice any sign or symptoms.

Directions

• this product does not contain directions or complete warnings for adult use.
• do not take more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• 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

Attention: For Single-Dose Cups, the entire dose should be taken.

Weight (lb)  Age (yr)Dose (mL)*
under 24               under 2 years         ask a doctor
24-35                   2-3 years                5 mL
36-47                   4-5 years                7.5 mL
48-59                   6-8 years                10 mL
60-71                   9-10 years              12.5 mL
72-95                   11 years                 15 mL

*or as directed by a doctor

Other Information

• each 5 mL contains: sodium: 2 mg
• Store at 20° to 25°C (68° to 77°F)
• grape flavored suspension supplied in the following oral dosage form:

   NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

   NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.
   NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

Inactive Ingredient

Inactive ingredients: acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

Manufactured By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R01/22

Principal Display Panel

Delivers 5 mL

NDC 0121-0966-05

DYE FREE/GRAPE FLAVOR

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

SEE INSERT