Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 4ecaba53-e879-405c-826a-5659686239b5
Route
ORAL
Published
Effective Date 2015-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (22.5 mg) Acetaminophen (4.6 mg) Caffeine (68 mg)
Inactive Ingredients
Cocoa Citric Acid Monohydrate Starch, Potato Talc Stearic Acid

Identifiers & Packaging

Pill Appearance
Shape: round Color: brown Size: 12 mm Score: 2
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1996-06-26

Description

One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

Purpose

Analgetic - antipyretic


Medication Information

Purpose

Analgetic - antipyretic

Description

One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

Uses

Effective in mild to moderate intensity pain (including headache, migraine, toothache, pain in osteoarthritis, arthritis, menalgia, algodismenorrhea, lumbago, sciatica, osteochondrosis, neuralgia, myalgia) and fever syndrome in acute infectious, infectious inflammatory diseases.

Section 50565-1

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control center immediately.

Section 51945-4

Warnings

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Prompt medical attention is critical even if you do not notice any signs or symptons.

Directions

Adults and children over 15 years take 1 tablet 2 - 3 times a day. The interval between the drug intakes should be at least 6 - 8 hours. Maximum single dose is 2 tablets, maximum daily dose is 4 tablets.

Other Information

Keep in a dry place at temperature below 77 ºF (25 ºC).

Active Ingredients

One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

Inactive Ingredients

Cocoa, Citric acid monohydrate, Potato starch, Talc, Stearic acid.


Structured Label Content

Uses

Effective in mild to moderate intensity pain (including headache, migraine, toothache, pain in osteoarthritis, arthritis, menalgia, algodismenorrhea, lumbago, sciatica, osteochondrosis, neuralgia, myalgia) and fever syndrome in acute infectious, infectious inflammatory diseases.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control center immediately.

Section 51945-4 (51945-4)

Purpose

Analgetic - antipyretic

Warnings

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Prompt medical attention is critical even if you do not notice any signs or symptons.

Directions

Adults and children over 15 years take 1 tablet 2 - 3 times a day. The interval between the drug intakes should be at least 6 - 8 hours. Maximum single dose is 2 tablets, maximum daily dose is 4 tablets.

Other Information (Other information)

Keep in a dry place at temperature below 77 ºF (25 ºC).

Active Ingredients (Active ingredients)

One tablet contains: Aspirin - 220 mg, Acetaminophen - 200 mg, Caffeine - 27 mg.

Inactive Ingredients (Inactive ingredients)

Cocoa, Citric acid monohydrate, Potato starch, Talc, Stearic acid.


Advanced Ingredient Data


Raw Label Data

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