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Childrens Acetaminophen by Pharmaceutical Associates, Inc.

Medically reviewed on March 21, 2017

Dosage form: suspension
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-1781

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Children's

Acetaminophen

Oral Suspension

Alcohol Free / Aspirin Free

DRUG FACTS

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

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 the 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 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
or as directed by a doctor
Weight (lbs)Age (yr)Dose (mL or tsp)
Under 24 Under 2 Ask a doctor
24-352-3 years5 mL (1 tsp)
36-474-5 years7.5 mL (1 ½ tsp)
48-596-8 years 10 mL (2 tsp)
60-719-10 years12.5 mL (2 ½ tsp)
72-9511 years15 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.

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

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-1781
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ACESULFAME 
BUTYLPARABEN 
CITRIC ACID MONOHYDRATE 
CORN SYRUP 
FD&C RED NO. 40 
GLYCERIN 
POLYSORBATE 80 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
XANTHAN GUM 
Product Characteristics
ColorredScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1781-0010 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
1NDC:0121-1781-055 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/17/2007
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693manufacture(0121-1781)

 
Pharmaceutical Associates, Inc.

← See all Childrens Acetaminophen brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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