c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d

SPL v2
SPL
SPL Set ID c6ee8b69-c791-4ed0-a2bb-44a229dbcb0d
Route
oral
Published
Effective Date 2013-02-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (500 mg)
Inactive Ingredients
lactose monohydrate starch, corn gelatin methylparaben propylparaben magnesium stearate talc sodium starch glycolate type a potato silicon dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 500mg Shape: round Color: white Size: 13 mm Score: 2
Marketing Status
otc monograph not final active Since 2013-03-01

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 500 mg


Medication Information

Uses





temporarily relieves minor aches and pains due to:



the common cold

headache

backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily reduces fever

Purpose

Pain reliever/fever reducer

Directions

do not take more than directed (see overdose warning)



adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

swallow whole – do not crush, chew, or dissolve

do not take more than 6 caplets in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor



children under 12 years : ask a doctor



Description

Acetaminophen 500 mg

Section 51727-6

LACTOSE MONOHYDRATE

Section 51945-4

Enter section text here

Warning

Liver warning:



This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take



more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product



Active Ingredient

Acetaminophen 500 mg

Keep Out of Reach of Children

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (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.


Structured Label Content

Uses (uses)





temporarily relieves minor aches and pains due to:



the common cold

headache

backache

minor pain of arthritis

toothache

muscular aches

premenstrual and menstrual cramps

temporarily reduces fever

Purpose (purpose)

Pain reliever/fever reducer

Directions (directions)

do not take more than directed (see overdose warning)



adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last

swallow whole – do not crush, chew, or dissolve

do not take more than 6 caplets in 24 hours, unless directed by a doctor

do not use for more than 10 days unless directed by a doctor



children under 12 years : ask a doctor



Section 51727-6 (51727-6)

LACTOSE MONOHYDRATE

Section 51945-4 (51945-4)

Enter section text here

Warning (warning)

Liver warning:



This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (3,000 mg) in 24 hours. Severe liver damage may occur if you take



more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product



Active Ingredient (active ingredient)

Acetaminophen 500 mg

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

Overdose warning:

In case of overdose, get medical help or contact a Poison Control Center right away (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)