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Childrens Acetaminophen by Pharmaceutical Associates, Inc.

Medically reviewed on Jan 12, 2018

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

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

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 (lb)Age (yr)Dose (mL or tsp)
or as directed by a doctor
Under 24Under 2Ask a doctor
24-352-3 years5 mL (1 tsp)
36-474-5 years7.5 mL (1 ½ tsp)
48-596-8 years10 mL (2 tsp)
60-719-10 years12.5 mL (2 ½ tsp)
72-9511 years15 mL (3 tsp)

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

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

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 (unit dose cups of 5 mL).

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 - 5 mL Cup Label

Delivers 5 mL
NDC 0121-1781-05

CHILDREN'S
ACETAMINOPHEN
ORAL SUSPENSION
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 potassium 
Butylparaben 
Citric Acid Monohydrate 
corn syrup 
FD&C Red No. 40 
glycerin 
Polysorbate 80 
Propylene Glycol 
Water 
Sodium Benzoate 
sorbitol 
Magnesium Aluminum Silicate 
Xanthan Gum 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-1781-0510 TRAY in 1 CASE
110 CUP, UNIT-DOSE in 1 TRAY
15 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34310/01/2014
Labeler - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693MANUFACTURE(0121-1781)

 
Pharmaceutical Associates, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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