SPL v2
SPL
SPL Set ID fd5918a5-a0b1-482e-95d5-0837b2ebc44f
Route
ORAL
Published
Effective Date 2013-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Butylparaben Carboxymethylcellulose Sodium Citric Acid Acetate Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Hydroxyethyl Cellulose (100 Mpa.s At 2%) Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-02-21

Description

Active Ingredient Acetaminophen 160 mg


Medication Information

Warnings and Precautions

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

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.

Indications and Usage

Uses

temporarily reduces fever

temporarily relieves minor aches and pains due to:

• the common cold • flu • headache

• sore throat • toothache

Dosage and Administration

Directions

• this product does not contain directions or

complete warnings for adult use.

• shake well before using

• find right dose on chart below. If possible, use

weight to dose; otherwise, use age.

• use only enclosed dosing cup designed for use

with this product. Do not use any other dosing

device.

• if needed, repeat dose every 4 hours while

symptoms last

• do not give more than 5 times in 24 hours

• do not give more than 5 days unless directed

by a doctor

Weight (lb)  Age (yr)  Dose (tsp or mL)

under 24          under 2              ask a doctor

24-35                2-3             1 teaspoon or 5 mL

36-47                4-5          1 1/2 teaspoons or 7.5 mL

48-59                6-8           2 teaspoons or 10 mL

60-71               9-10         2 1/2 teaspoons or 12.5 mL

72-95                 11            3 teaspoons or 15 mL

Description

Active Ingredient Acetaminophen 160 mg

Section 50565-1

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the

recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek

professional assistance or contact a Poison Control

Center immediately. Quick medical attention is

critical even if you do not notice any signs or

symptoms.

Section 50566-9

Stop use and ask a doctor if

• new symptoms occur

• redness or swelling is present

• pain gets worse or lasts more than 5 days

• fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Section 50567-7

When using this product

• do not exceed recommended dose

(see overdose warning)

Section 50568-5

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

Section 50569-3

Ask a doctor before use if your child has

liver disease.

Section 51727-6

Inactive Ingredients

acesulfame potassium, butyl paraben,

carboxymethylcellulose sodium, cellulose, citric acid,

flavors, glycerin, high fructose corn syrup, propylene

glycol, purified water, red 40, sodium benzoate,

sorbitol, xanthan gum

Section 51945-4

Section 55105-1

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Section 55106-9

Active Ingredient

Acetaminophen 160 mg

Section 60561-8

Other information

• store at controlled room temperature

• see bottom panel for lot number and

expiration date


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily reduces fever

temporarily relieves minor aches and pains due to:

• the common cold • flu • headache

• sore throat • toothache

Dosage and Administration (34068-7)

Directions

• this product does not contain directions or

complete warnings for adult use.

• shake well before using

• find right dose on chart below. If possible, use

weight to dose; otherwise, use age.

• use only enclosed dosing cup designed for use

with this product. Do not use any other dosing

device.

• if needed, repeat dose every 4 hours while

symptoms last

• do not give more than 5 times in 24 hours

• do not give more than 5 days unless directed

by a doctor

Weight (lb)  Age (yr)  Dose (tsp or mL)

under 24          under 2              ask a doctor

24-35                2-3             1 teaspoon or 5 mL

36-47                4-5          1 1/2 teaspoons or 7.5 mL

48-59                6-8           2 teaspoons or 10 mL

60-71               9-10         2 1/2 teaspoons or 12.5 mL

72-95                 11            3 teaspoons or 15 mL

Warnings and Precautions (34071-1)

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

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.

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Overdose Warning: Taking more than the

recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek

professional assistance or contact a Poison Control

Center immediately. Quick medical attention is

critical even if you do not notice any signs or

symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• new symptoms occur

• redness or swelling is present

• pain gets worse or lasts more than 5 days

• fever gets worse or lasts more than 3 days

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

• do not exceed recommended dose

(see overdose warning)

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child is

taking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

Ask a doctor before use if your child has

liver disease.

Section 51727-6 (51727-6)

Inactive Ingredients

acesulfame potassium, butyl paraben,

carboxymethylcellulose sodium, cellulose, citric acid,

flavors, glycerin, high fructose corn syrup, propylene

glycol, purified water, red 40, sodium benzoate,

sorbitol, xanthan gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active Ingredient

Acetaminophen 160 mg

Section 60561-8 (60561-8)

Other information

• store at controlled room temperature

• see bottom panel for lot number and

expiration date


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)