FDA Label for Childrens Acetaminophen

Active Ingredient (In Each 5 Ml Teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

Temporarily:

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

  
  

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

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

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 the 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; tsp = teaspoonful
• find the 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 (lbs)	Age (yr)	Dose (mL or tsp) or as directed by a doctor
Under 24	Under 2	Ask a doctor
24-35	2-3 years	5 mL (1 tsp)
36-47	4-5 years	7.5 mL (1 ½ tsp)
48-59	6-8 years	10 mL (2 tsp)
60-71	9-10 years	12.5 mL (2 ½ tsp)
72-95	11 years	15 mL (3 tsp)

Other Information

• sodium content: 2 mg/5 mL 
• store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
• protect from freezing
• a red, berry flavored suspension supplied in the following oral dosage form:

NDC 0121-1781-05:  5 mL unit dose cup

NDC 0121-1781-00:  Case contains 100 unit dose cups of 5 mL (0121-1781-05) packaged in 10 trays of 10 unit dose cups each.

Inactive Ingredients

Acesulfame K, butylparaben, citric acid, corn syrup, FD&C Red No. 40, flavoring, glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

You may also report serious side effects to this phone number.

Other

Pharmaceutical
Associates, Inc. Greenville, SC 29605
www.paipharma.com

R01/17

Principal Display Panel - 5 Ml Cup

Delivers 5 mL

NDC 0121-1781-05

C HILDREN'S

A CETAMINOPHEN

O RAL S USPENSION

160 mg/5 mL

Alcohol Free / Aspirin Free

SHAKE WELL

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

A17810501

5 mL Unit Dose Cup Label - acetaminophen 01