SPL v3
SPL
SPL Set ID e9dbbbcd-9ab7-aa10-e053-2995a90acd24
Route
ORAL
Published
Effective Date 2022-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (150 mg) Caffeine (12.5 mg)
Inactive Ingredients
Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: JW Shape: oval Color: brown Size: 20 mm Score: 1
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-09-30

Description

Acetaminophen, Caffeine Anhydrous,


Medication Information

Warnings and Precautions

■ When using this product Stop use and ask a doctor if nervousness, diziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days. fever gets worse or lasts more than 3 days New symtoms occur. keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away. If pregnant or breast-feeding, ask a health professional before use.

Indications and Usage

■ Adult and children 15 years of age and older: 2 capsules three times a day ■ Children under 15 years of age: ask a doctor

Dosage and Administration

for oral use

Description

Acetaminophen, Caffeine Anhydrous,

Section 50565-1

Keep out of reach of children

Section 51727-6

magnesium stearate, corn, starch, etc

Section 51945-4

Section 55105-1

■ relieve your cold symptoms • cold • Rhinitis

Section 55106-9

Acetaminophen, Caffeine Anhydrous,


Structured Label Content

Indications and Usage (34067-9)

■ Adult and children 15 years of age and older: 2 capsules three times a day ■ Children under 15 years of age: ask a doctor

Dosage and Administration (34068-7)

for oral use

Warnings and Precautions (34071-1)

■ When using this product Stop use and ask a doctor if nervousness, diziness, or sleepness occur. Pain, nasal congestion or cough gets worse or lasts more than 7 days. fever gets worse or lasts more than 3 days New symtoms occur. keep out of reach of children. In case of overdose, get medical help or contact a poison contral center right away. If pregnant or breast-feeding, ask a health professional before use.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

magnesium stearate, corn, starch, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

■ relieve your cold symptoms • cold • Rhinitis

Section 55106-9 (55106-9)

Acetaminophen, Caffeine Anhydrous,


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)