Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c757a03e-59ea-469c-970d-4bc62e73f36f
Route
ORAL
Published
Effective Date 2018-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (60 mg) Chlorpheniramine (0.667 mg)
Inactive Ingredients
Ilex Asprella Root Melicope Pteleifolia Root Chrysanthemum Indicum Flower Vitex Negundo Whole Lonicera Japonica Flower Strobilanthes Cusia Root Starch, Corn Sucrose Water Fd&c Yellow No. 5 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: GM Shape: round Color: yellow Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-11-26 Until 2029-08-30

Description

Active ingredient (in each tablet) Acetaminophen 60 mg Chlorpheniramine maleate 0.667 mg


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies:

minor aches and pains

headache

muscular aches

fever

sore throat

sneezing

itching of the nose or throat

runny nose

itchy, watery eyes

Dosage and Administration

Directions

adults and children 12 years of age and older: Take 6 tablets every 4 hours, not more than 36 tablets in 24 hours

children 6 to under 12 years of age: Take 3 tablets every 4 hours, not more than 18 tablets in 24 hours

children under 6 years: consult a doctor

Description

Active ingredient (in each tablet) Acetaminophen 60 mg Chlorpheniramine maleate 0.667 mg

Section 44425-7

Other information

protect from light our excessive heat

keep tightly closed

keep in dry place

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control

Center right away. Prompt medical attention is critical for adults as well as for children even if you do

not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

pain or fever persists or worsen

new symptoms occur

redness or swelling is present

sore throat:

     is severe

     last for more than 2 days

is accompanied or followed by:

     fever

     headache

     rash

     nausea

     vomiting

Section 50567-7

When using this product

may cause excitability especially in children

may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)

avoid alcoholic beverages

use caution when driving a motor vehicle or operating machinery

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

Section 50569-3

Ask a doctor before use if the user has

glaucoma

a breathing problem such as emphysema or chronic bronchitis

difficulty in urination due to enlargement of the prostate gland

Section 50570-1

Do not use

for pain for more than 10 days

for fever for more than 3 days

Section 51727-6

Inactive ingredients

Rough-leaved holly root, evodia root, wild chrysanthemum flower, Chinese chaste tree twig, honeysuckle flower, strobilanthes cusia root, cornstarch, sucrose, water, FD&C yellow no.5 and FD&C yellow no.6.

Section 51945-4

GANMAOLING TABLETS, NDC 72030-002-01, Antihistamine, Pain Reliever-Fever Reducer, 120 Tablets

Section 53413-1

Questions or Comments? (888) 221-3496M-F 9 am to 5 pm

you may also use this number to report serious adverse events associated with the use of this product

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever-fever reducer

Antihistamine

Section 55106-9

Active ingredient (in each tablet)

Acetaminophen 60 mg

Chlorpheniramine maleate 0.667 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves the following symptoms associated with the common cold, hay fever, or other upper respiratory allergies:

minor aches and pains

headache

muscular aches

fever

sore throat

sneezing

itching of the nose or throat

runny nose

itchy, watery eyes

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and older: Take 6 tablets every 4 hours, not more than 36 tablets in 24 hours

children 6 to under 12 years of age: Take 3 tablets every 4 hours, not more than 18 tablets in 24 hours

children under 6 years: consult a doctor

Warnings and Precautions (34071-1)

Warnings

Section 44425-7 (44425-7)

Other information

protect from light our excessive heat

keep tightly closed

keep in dry place

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control

Center right away. Prompt medical attention is critical for adults as well as for children even if you do

not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

pain or fever persists or worsen

new symptoms occur

redness or swelling is present

sore throat:

     is severe

     last for more than 2 days

is accompanied or followed by:

     fever

     headache

     rash

     nausea

     vomiting

Section 50567-7 (50567-7)

When using this product

may cause excitability especially in children

may cause drowsiness (alcohol, sedatives, and tranquilizers may increase the drowsiness effect)

avoid alcoholic beverages

use caution when driving a motor vehicle or operating machinery

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if the user has

glaucoma

a breathing problem such as emphysema or chronic bronchitis

difficulty in urination due to enlargement of the prostate gland

Section 50570-1 (50570-1)

Do not use

for pain for more than 10 days

for fever for more than 3 days

Section 51727-6 (51727-6)

Inactive ingredients

Rough-leaved holly root, evodia root, wild chrysanthemum flower, Chinese chaste tree twig, honeysuckle flower, strobilanthes cusia root, cornstarch, sucrose, water, FD&C yellow no.5 and FD&C yellow no.6.

Section 51945-4 (51945-4)

GANMAOLING TABLETS, NDC 72030-002-01, Antihistamine, Pain Reliever-Fever Reducer, 120 Tablets

Section 53413-1 (53413-1)

Questions or Comments? (888) 221-3496M-F 9 am to 5 pm

you may also use this number to report serious adverse events associated with the use of this product

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever-fever reducer

Antihistamine

Section 55106-9 (55106-9)

Active ingredient (in each tablet)

Acetaminophen 60 mg

Chlorpheniramine maleate 0.667 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)