DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-10-10

Medication Information

Purpose

Pain reliver/fever reducer

Description

Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg

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.

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.

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.

Drug Facts

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

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.

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

Keep Out of Reach of Children.

Keep out of reach of children.

Ask A Doctor Before Use If Your Child Has

liver disease

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

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)

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.

Structured Label Content

Uses

temporarily reduces

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

Purpose

Pain reliver/fever reducer

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.

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.

Do Not Use (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.

Drug Facts

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Overdose Warning (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.

Other Information (Other information)

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

Inactive Ingredients (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

Keep Out of Reach of Children. (Keep out of reach of children.)

Keep out of reach of children.

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

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

Ask A Doctor Or Pharmacist Before Use If Your Child Is (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) (When using this product do not exceed recommended dose (see overdose warning))

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.

Advanced Ingredient Data

[{"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily reduces fever relieves minor aches and pains to: the common cold flu headache sore throat toothache", "Purpose": "Pain reliver/fever reducer", "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.", "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.", "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.", "Drug Facts": "Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg", "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.", "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", "Keep out of reach of children.": "Keep out of reach of children.", "Ask a doctor before use if your child has": "liver disease", "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", "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)": "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."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information