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Childrens Pain and Fever by Marc Glassman, Inc.

Dosage form: liquid
Ingredients: ACETAMINOPHEN 160mg in 5mL
Labeler: Marc Glassman, Inc.
NDC Code: 68998-525

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.

Drug Facts
Active ingredient

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Purpose

Pain reliver/fever reducer

Keep out of reach of children.

Keep out of reach of children.

Uses

temporarily reduces

  • fever
  • relieves minor aches and pains to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

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 maxium daily amount
  • with other drugs conntaining 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.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

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.

When using this product do not exceed recommended dose (see overdose warning)
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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right awway. (1-800-222-1222) Quick 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.
  • shake well before using
  • mL = milliliter; tsp = teaspoonful
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • 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
 Weight (lb) Age (yr) Dose (mL or tsp)*
 under 24 under 2 years ask a doctor
 24-35 2-3 years 5 mL (1 tsp)
 36-47 4-5 years 7.5 mL (1 1/2 tsp)
 48-59 6-8 years 10 mL (2 tsp)
 60-71 9-10 years 12.5 mL (2 1/2 tsp)
 72-95 11 years 15 mL (3 tsp)

* or use as directed

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

Other information
  • each 5 mL (1 tsp) contains: sodium 3 mg
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

anhydrous citric acid, butylparaben, FD and C red # 40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Marcs Childrens Pain and Fever Product Label

NDC 68998-525-24

Compare to the active ingredient in childrens Tylenol® oral suspension*

MARCS

Childrens

Pain and Fever

Pain Reliver / Fever Reducer

Acetaminophen Oral Suspension

  • Alcohol-Free
  • Ibuprofen Free
  • Asprin Free

For Ages 2 to 11

CHERRY FLAVOR

4 FL OZ (118 mL)

160 mg per 5 mL

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

* This product is not manufactured or distributed by McNeil Consumer Healthcare, Distributer of Childrens Tylenol® Oral Suspension

Distributed by:

Marc Glassman, Inc.

West 130th Street

Cleveland, OH 44130

BX-045

LR-076

Lot:

Exp:

CHILDRENS PAIN AND FEVER 
acetaminophen liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68998-525
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
FD&C RED NO. 40 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
CARBOXYMETHYLCELLULOSE SODIUM 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
SUCRALOSE 
XANTHAN GUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68998-525-24118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/10/2014
Labeler - Marc Glassman, Inc. (094487477)

Revised: 08/2015
 
Marc Glassman, Inc.

← See all Childrens Pain and Fever brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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