CHILDRENS PAIN AND FEVER- acetaminophen liquid

Childrens Pain and Fever by

Drug Labeling and Warnings

Childrens Pain and Fever by is a Otc medication manufactured, distributed, or labeled by Marc Glassman, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive 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 maximum daily amount
■ with other drugs containing acetaminophen

Allergy alert
Acetaminophen may cause severe skin reactions.
Symptoms may include: ■ skin reddening ■ blisters
■ rash. If 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.
• 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:

rres

INGREDIENTS AND APPEARANCE

CHILDRENS PAIN AND FEVER 
acetaminophen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68998-525
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68998-525-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/10/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/10/2014

Labeler - Marc Glassman, Inc. (094487477)