LIQUID ACETAMINOPHEN- acetaminophen liquid 
KRAMER NOVIS

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.

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Liquid Acetaminophen

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

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

image description

LIQUID ACETAMINOPHEN 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52083-663
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)  
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    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52083-663-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product03/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/02/2020
Labeler - KRAMER NOVIS (090158395)

Revised: 3/2020
Document Id: 3e3dc8bf-a1ea-41f2-8257-ce9c4b7e22d3
Set id: 126352fe-3716-4395-8622-68ce5c0053ef
Version: 1
Effective Time: 20200302
 
KRAMER NOVIS