DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (200 mg) Guaifenesin (41.6 mg) Pseudoephedrine (15 mg) Methylephedrine, (+/-)- (12.5 mg) Cloperastine (8 mg) Chlorpheniramine (1.25 mg)

Inactive Ingredients

Starch, Corn

Identifiers & Packaging

Pill Appearance

Shape: oval Color: brown Size: 22 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2018-11-22

Medication Information

Warnings and Precautions

Warnings

When using this product

Do not use for a period longer than 1 weeks

Stop use and ask a doctor if nervousness, dizziness, 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 symptoms occur

These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away

Indications and Usage

■ adult and children 12 years of age and older: 2 capsules every 5 hours

■ children under 12 years of age: ask a doctor

Dosage and Administration

For oral use only

Description

Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, DL-Methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate

Section 50565-1

Keep out of reach of children

Section 51727-6

camauba wax cellulose, starch

Section 51945-4

Section 55105-1

relieve your cold symptoms

Section 55106-9

Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, DL-Methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate

Structured Label Content

Indications and Usage (34067-9)

■ adult and children 12 years of age and older: 2 capsules every 5 hours

■ children under 12 years of age: ask a doctor

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

Warnings

When using this product

Do not use for a period longer than 1 weeks

Stop use and ask a doctor if nervousness, dizziness, 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 symptoms occur

These may be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

camauba wax cellulose, starch

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

relieve your cold symptoms

Section 55106-9 (55106-9)

Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, DL-Methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate

Advanced Ingredient Data

[{"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "41.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PSEUDOEPHEDRINE", "unii": "7CUC9DDI9F", "classCode": "ACTIB", "strengthNumerator": "15", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "METHYLEPHEDRINE, (+/-)-", "unii": "SHS9PGQ2LS", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CLOPERASTINE", "unii": "69M5L7BXEK", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "1.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "■ adult and children 12 years of age and older: 2 capsules every 5 hours ■ children under 12 years of age: ask a doctor", "34068-7": "For oral use only", "34071-1": "Warnings When using this product Do not use for a period longer than 1 weeks Stop use and ask a doctor if nervousness, dizziness, 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 symptoms occur These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children, In case of overdose, get medical help or contact a poison control center right away", "50565-1": "Keep out of reach of children", "51727-6": "camauba wax cellulose, starch", "55105-1": "relieve your cold symptoms", "55106-9": "Acetaminophen, Guaifenesin, Pseudoephedrine Hydrochloride, DL-Methylephedrine Hydrochloride, Cloperastine Hydrochloride, Chlorpheniramine Maleate"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information