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SPL v2

SPL

SPL Set ID f2e951c9-afac-7e2e-e053-2a95a90a5020

Route

ORAL

Published

Effective Date 2023-01-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (2.5 mg) Acetaminophen (200 mg)

Inactive Ingredients

Trisodium Citrate Dihydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2023-01-23

Description

Acetaminophen, Chlorpheniramine Maleate

Medication Information

Warnings and Precautions

see product label

Indications and Usage

■ Adult and children 16 years and over: take 1 bottle (20ml) per session 3 times per day after meal

Dosage and Administration

for oral use

Description

Acetaminophen, Chlorpheniramine Maleate

Section 50565-1

Keep out of reach of children

Section 51727-6

sodium citrate dihydrate, L-sodium glutamate, sugar, d-sorbitol solution, distilled water

Section 51945-4

Section 55105-1

temporarily relieves thee symptoms due to cold or flu

minor aches and pains headache, nasal congestion, runny nose, cough, sneezing, sore throat

Section 55106-9

Acetaminophen, Chlorpheniramine Maleate

Structured Label Content

Indications and Usage (34067-9)

■ Adult and children 16 years and over: take 1 bottle (20ml) per session 3 times per day after meal

Dosage and Administration (34068-7)

for oral use

Warnings and Precautions (34071-1)

see product label

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

sodium citrate dihydrate, L-sodium glutamate, sugar, d-sorbitol solution, distilled water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

temporarily relieves thee symptoms due to cold or flu

minor aches and pains headache, nasal congestion, runny nose, cough, sneezing, sore throat

Section 55106-9 (55106-9)

Acetaminophen, Chlorpheniramine Maleate

Advanced Ingredient Data

[{"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "20", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "■ Adult and children 16 years and over: take 1 bottle (20ml) per session 3 times per day after meal", "34068-7": "for oral use", "34071-1": "see product label", "50565-1": "Keep out of reach of children", "51727-6": "sodium citrate dihydrate, L-sodium glutamate, sugar, d-sorbitol solution, distilled water", "55105-1": "temporarily relieves thee symptoms due to cold or flu minor aches and pains headache, nasal congestion, runny nose, cough, sneezing, sore throat", "55106-9": "Acetaminophen, Chlorpheniramine Maleate"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:07.015699 · Updated: 2026-03-14T23:01:17.657881