ACETAMINOPHEN- acetaminophen liquid 
Westminster Pharmaceuticals, LLC

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Acetaminophen

Drug Facts

Active ingredient (in each 5 mL teaspoonful)

Acetaminophen, USP 160 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with:

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 that contain 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.

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
  • redness or swelling is present
  • any new symptoms appear.

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. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Weight (lbs.)Age (years)Dosage Teaspoonful (tsp)*
*
or as directed by a doctor
Under 24Under 2Consult a doctor
24 to 352 to under 45 mL (1 tsp)
36 to 474 to under 67.5 mL (1 1/2 tsp)
48 to 596 to under 910 mL (2 tsp)
60 to 719 to under 1112.5 mL (2 1/2 tsp)
72 to 9511 to under 1215 mL (3 tsp)

Other information

Inactive ingredients

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, Sorbitol Solution, Sucralose.

Questions?

You may report side effects by calling Westminster M-F (9 a.m. to 5 p.m. EST), at 1-844-221-7294 or FDA at 1-800-FDA-1088.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NDC 69367-323-04

Children's
Acetaminophen
Liquid

160 mg/5 mL

Pain Reliever / Fever Reducer
Sugar Free / Alcohol Free
Aspirin Free
CHERRY FLAVOR

4 fl. oz. (118 mL)

Westminster
Pharmaceuticals

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69367-323
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
ColorREDScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69367-323-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2021
2NDC:69367-323-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM01305/05/2021
Labeler - Westminster Pharmaceuticals, LLC (079516651)

Revised: 5/2021
Document Id: f382f280-b5cf-4f4b-869b-285ed012c19e
Set id: ace5ebac-ec11-4c26-b1e3-954b450ee671
Version: 6
Effective Time: 20210504
 
Westminster Pharmaceuticals, LLC