SPL v1
SPL
SPL Set ID d0b20c56-de2a-1489-e053-2995a90a6a06
Route
ORAL
Published
Effective Date 2021-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (200 mg) Dextromethorphan (15 mg) Chlorpheniramine (2.5 mg)
Inactive Ingredients
Sodium Benzoate

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-11-14

Description

ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMID


Medication Information

Warnings and Precautions

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 16 years and over: take 1 bottle per session 3 times a day after meal

children 11 to 15 years: take 2/3 bottle once a day

children 7 to 10 years: take 1/2 bottle once a day

children 3 to 6 years: take 1/3 bottle once a day

children 2 years: take 1/4 bottle once a day

under 2 years: ask a doctor

Dosage and Administration

For oral use only

Description

ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMID

Section 50565-1

Keep out of reach of children

Section 51727-6

SODIUM BENZOATE, CITRIC ACID MONOHYDRATE,

SODIUM CITRATE DIHYDRATE, L-SODIUM GLUTAMATE, SUGAR,

D-SORBITOL SOLUTION, DISTILLED WATER

Section 51945-4

Section 55105-1

First symtoms of a cold(snot, nasal stuffiness, sneeze, throat pain, cough, phlegm, chill, pyrexia, headache, arthralgia, myalgia) alleviate

Section 55106-9

ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMID


Structured Label Content

Indications and Usage (34067-9)

adult and children 16 years and over: take 1 bottle per session 3 times a day after meal

children 11 to 15 years: take 2/3 bottle once a day

children 7 to 10 years: take 1/2 bottle once a day

children 3 to 6 years: take 1/3 bottle once a day

children 2 years: take 1/4 bottle once a day

under 2 years: ask a doctor

Dosage and Administration (34068-7)

For oral use only

Warnings and Precautions (34071-1)

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)

SODIUM BENZOATE, CITRIC ACID MONOHYDRATE,

SODIUM CITRATE DIHYDRATE, L-SODIUM GLUTAMATE, SUGAR,

D-SORBITOL SOLUTION, DISTILLED WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

First symtoms of a cold(snot, nasal stuffiness, sneeze, throat pain, cough, phlegm, chill, pyrexia, headache, arthralgia, myalgia) alleviate

Section 55106-9 (55106-9)

ACETAMINOPHENE. CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMID


Advanced Ingredient Data


Raw Label Data

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