FDA Label for Childrens Acetaminophen

Other

DRUG FACTS

When using this product, do not exceed the recommended dose (see overdose warning)

Pharmaceutical
Associates, Inc.

Greenville, SC 29605
www.paipharma.com

Distributed by:

Cardinal Health

Dublin, OH 43017

L55345730519

R01/17

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:

.

Overbagged with 5 - (5 mL unit dose cups) per bag, NDC 55154-5787-5

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.

Principal Display Panel

Children’s Acetaminophen

Oral Solution 160 mg/5 mL

5 Cups