LIQUID ACETAMINOPHEN- acetaminophen liquid

Liquid Acetaminophen by

Drug Labeling and Warnings

Liquid Acetaminophen by is a Otc medication manufactured, distributed, or labeled by KRAMER NOVIS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each 5 mL tsp)

Acetaminophen, 160 mg

Purpose

Pain reliever/Fever reducer

Uses:

Temporarily relieves of minor aches and pains due to  headache backache  muscular aches  minor pain of arthritis the common cold  toothache  premenestrual and menstrual cramps

Temporarily reduces fever.

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

adults take more than 6 doses in 24 hours, which is the maximum daily amount

child takes more than 5 doses in 24 hours, which is the maximum daily amount 

taken with other drugs containing acetaminophen (prescription or nonprescription) 

adults has 3 or more alcoholic drinks while using this product

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

Do not use with any other product containing acetaminophen (prescription or nonprescription), this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

WHEN USING THIS PRODUCT, DO NOT EXCEED RECOMMENDED DOSE 

Ask a doctor before use if you have a liver disease.

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

Stop use and ask a doctor if pain gets worse or lasts more than 10 days in adults 

pain gets worse or lasts more than 5 days in children under 12 years

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.

If pregnant or breast-feeding, ask a health professional before use.

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

Directions

Dosage may be repeated every 4 hours, or as directed by doctor.

Do not exceed recommended dose.

Find dose in chart below. If possible, use weight to dose, otherwise use age.

Weight  (lbs)	Under 24	24-35	36-47	48-59	60-71	72-95	Over 95
Age (years)	Under 2	2 to 3	4 to 5	6 to 8	9 to 10	11	12 to adult
Dosage  teaspoonful  (tsp)	consult a doctor	1 tsp (5 mL)	1 1/2 tsp; (7.5 mL)	2 tsp; (10 mL)	2 1/2 tsp; (12.5 mL)	3 tsp; (15 mL)	4 tsp; (20 mL)

Other information

Store at controlled room tempearature 15°-30°C (59°-86°F). Do not refrigerate. 

Protect from light. Avoid excessive heat or humidity.

Inactive ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, sucralose

Questions or comments?

Call weekdays from 8 AM to 4 PM AST at 787-767-2072.

Manufactured in the USA for Kramer Novis, San Juan, PR 00917

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Tylenol® Liquid*

√ Alcohol Free

√ Aspirin Free

Cherry  Flavor

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol® Liquid.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

www.kramernovis.com

Packaging

INGREDIENTS AND APPEARANCE

LIQUID ACETAMINOPHEN 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52083-663
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)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52083-663-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	03/02/2020

Labeler - KRAMER NOVIS (090158395)