Acetaminophen by Westminster Pharmaceuticals, LLC ACETAMINOPHEN liquid

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Westminster Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• the common cold
• flu
• sore throat
• headache
• toothache
• and to reduce fever

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

• this product does not contain directions or complete warnings for adult use
• use only the enclosed dosing cup designed for use with this product
• if possible, use weight to dose, otherwise use age
• dose may be repeated every 4 hours, while symptoms persist, up to five times a day or as directed by a doctor

Weight (lbs.)	Age (years)	Dosage Teaspoonful (tsp)*
* or as directed by a doctor
Under 24	Under 2	Consult a doctor
24 to 35	2 to under 4	5 mL (1 tsp)
36 to 47	4 to under 6	7.5 mL (1 1/2 tsp)
48 to 59	6 to under 9	10 mL (2 tsp)
60 to 71	9 to under 11	12.5 mL (2 1/2 tsp)
72 to 95	11 to under 12	15 mL (3 tsp)

Other information

• Each 5 mL contains: Sodium 3 mg
• If dispensed, dispense in a tight, light resistant container with a child-resistant cap.
• Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

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

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69367-323
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	160 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69367-323-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2021
2	NDC: 69367-323-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M013	05/05/2021

Labeler - Westminster Pharmaceuticals, LLC (079516651)