Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID fc3d9754-8aa8-47cd-9a5a-13c1f7589294
Route
ORAL
Published
Effective Date 2015-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (80 mg)
Inactive Ingredients
Aspartame Croscarmellose Sodium D&c Red No. 7 Mannitol Cellulose, Microcrystalline Silicon Dioxide Stearic Acid Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: AZ023 Shape: round Color: pink Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-03-03

Description

Acetaminophen 80 mg

Purpose

Analgesic/Antipyretic


Medication Information

Purpose

Analgesic/Antipyretic

Description

Acetaminophen 80 mg

Uses

temporary relief of minor aches and pains associated with common cold and flu headache toothache sore throat immunizations and reduction of fever

Directions

this product does not contain directions or complete warnings for adult usechew tablets before swallowing all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period follow the chart below for proper dosing or as directed by a doctor if possible, use weight for dosing, otherwise use age

Weight (lbs)

Under 24

24-35

36-47

48-59

60-71

72-95

Age (yrs)

Under 2

2-3

4-5

6-8

9-10

11

Tablets

Consult a doctor

2

3

4

5

6

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

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen

Active Ingredient

Acetaminophen 80 mg

Other Information

Phenylketonurics: contains phenylalanine 2.8 mg per tablet store at room temperature protect from excessive moisture do not use if imprinted safety seal under cap is broken or missing

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

Inactive Ingredients

aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose

When Using This Product

do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

Stop Use and Ask A Doctor If

symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present You may report side effects to 888-952-0050

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms

Package/label Principal Display Panel
Ask Doctor Or Pharmacist Before Use If

the user is taking the blood thinning drug warfarin

Ask Doctor Before Use If Your Child Has

liver disease


Structured Label Content

Uses

temporary relief of minor aches and pains associated with common cold and flu headache toothache sore throat immunizations and reduction of fever

Purpose

Analgesic/Antipyretic

Directions

this product does not contain directions or complete warnings for adult usechew tablets before swallowing all dosages may be repeated every 4 hours, but not more than 5 doses in a 24 hour period follow the chart below for proper dosing or as directed by a doctor if possible, use weight for dosing, otherwise use age

Weight (lbs)

Under 24

24-35

36-47

48-59

60-71

72-95

Age (yrs)

Under 2

2-3

4-5

6-8

9-10

11

Tablets

Consult a doctor

2

3

4

5

6

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

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours taken with other drugs containing acetaminophen

Active Ingredient (Active ingredient)

Acetaminophen 80 mg

Other Information (Other information)

Phenylketonurics: contains phenylalanine 2.8 mg per tablet store at room temperature protect from excessive moisture do not use if imprinted safety seal under cap is broken or missing

Sore Throat Warning (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

Inactive Ingredients

aspartame, croscarmellose sodium, D&C red #7, flavors, mannitol, microcrystalline cellulose, silicon dioxide, stearic acid, sucrose

When Using This Product (When using this product)

do not exceed recommended dose; taking more than the recommended dose (overdose) may not provide more relief and could cause serious health problems

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

symptoms do not improve pain gets worse or lasts more than 5 days fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present You may report side effects to 888-952-0050

Keep Out of Reach of Children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical even if you do not notice any signs or symptoms

Package/label Principal Display Panel (Package/Label Principal Display Panel)
Ask Doctor Or Pharmacist Before Use If (Ask doctor or pharmacist before use if)

the user is taking the blood thinning drug warfarin

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

liver disease


Advanced Ingredient Data


Raw Label Data

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