SPL v1
SPL
SPL Set ID 7b0deef1-121d-4663-e053-2991aa0ab4b7
Route
ORAL
Published
Effective Date 2018-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Caffeine (50 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Corn Powdered Cellulose Magnesium Stearate Starch, Corn

Identifiers & Packaging

Pill Appearance
Imprint: SARIDON Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-11-20

Description

Acetaminophen, Caffeine Anhydrous


Medication Information

Warnings and Precautions

Do not use if carton is open or if printed bottle neck band or inner foil seal is broken.physician

Keep out of the reach of children. This package contains enough drug to seriously harm a child. Do not use with other drugs containing acetaminophen.

Use the smallest effective dose. Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage.

Do not take if allergic to acetaminophen. Consult a doctor if: your symptoms last for more than 5 days or fever lasts more than 3 days or you develop allergic reactions such as wheezing, rash or itching.

Ask a doctor or pharmacist before use if you: Are pregnant or breastfeeding, have chronic alcoholism; have a serious liver or kidney disease; use any other medications including natural health products, prescription drugs, salicylates or other pain and fever relief medications.

In case of overdose, call a Poison Control Centre or doctor immediately, even if you do not notice any possible signs or symptoms such as increased sweating, nausea, vomiting, stomach pain, and loss of appetite.

Indications and Usage

■ adult and children 12 years of age and older: 1 capsules three times a day

■ children under 12 years of age: ask a doctor

Dosage and Administration

For oral use only

Description

Acetaminophen, Caffeine Anhydrous

Section 50565-1

Keep out of reach of children

Section 51727-6

cellulose, corn starch, magnesium stearate, sodium starch glycolate

Section 51945-4

Section 55105-1

relief of: Headaches, Aches, Pain and Fever

Section 55106-9

Acetaminophen, Caffeine Anhydrous


Structured Label Content

Indications and Usage (34067-9)

■ adult and children 12 years of age and older: 1 capsules three times a day

■ children under 12 years of age: ask a doctor

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

Do not use if carton is open or if printed bottle neck band or inner foil seal is broken.physician

Keep out of the reach of children. This package contains enough drug to seriously harm a child. Do not use with other drugs containing acetaminophen.

Use the smallest effective dose. Do not take more than the maximum daily dose. Overdose may result in severe or possibly fatal liver damage.

Do not take if allergic to acetaminophen. Consult a doctor if: your symptoms last for more than 5 days or fever lasts more than 3 days or you develop allergic reactions such as wheezing, rash or itching.

Ask a doctor or pharmacist before use if you: Are pregnant or breastfeeding, have chronic alcoholism; have a serious liver or kidney disease; use any other medications including natural health products, prescription drugs, salicylates or other pain and fever relief medications.

In case of overdose, call a Poison Control Centre or doctor immediately, even if you do not notice any possible signs or symptoms such as increased sweating, nausea, vomiting, stomach pain, and loss of appetite.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

cellulose, corn starch, magnesium stearate, sodium starch glycolate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

relief of: Headaches, Aches, Pain and Fever

Section 55106-9 (55106-9)

Acetaminophen, Caffeine Anhydrous


Advanced Ingredient Data


Raw Label Data

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