INFANTS ACETAMINOPHEN CONCENTRATED - acetaminophen suspension/ drops 
Western Family Foods Inc

Western Family Infants' Acetaminophen Concentrated Drops Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg


Fever reducer/pain reliever



  • reduces fever
  • relieves minor aches and pains 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

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.

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

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 reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.


  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dropper designed for use with this product. Do not use any other dosing device.
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • replace dropper tightly to maintain child resistance
  • this product does not contain directions or complete warnings for adult use
Dosing Chart
Weight(lb) Age(yr) Dose (mL)
under 24 under 2 years ask a doctor
24-35 2–3 years 1.6 mL (0.8 + 0.8 mL)

Attention: use only enclosed dropper specifically designed for use with this product. Do not use any other dosing device.

Other information

  • store at 20°-25°C (68°-77°F)
  • do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Principal Display Panel

See New Warnings Information

Pain Reliever - Fever Reducer



Concentrated Drops

Aspirin Free

Ibuprofen Free

Alcohol Free

Use only with enclosed dropper

Grape Flavor

Compare to Concentrated Tylenol® Infants’ Drops active ingredient

80 mg per 0.8 mL

Infants' Acetaminophen Concentrated Drops Carton

Infants' Acetaminophen Concentrated Drops Carton

acetaminophen  suspension/ drops
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 55312-289
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
No Inactive Ingredients Found
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
# NDC Package Description Multilevel Packaging
1 55312-289-10 1 BOTTLE In 1 CARTON contains a BOTTLE
1 30 mL In 1 BOTTLE This package is contained within the CARTON (55312-289-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 12/27/2005

Labeler - Western Family Foods Inc (192166072)
Revised: 06/2009Western Family Foods Inc