drug facts

drug facts
SPL v3
SPL
SPL Set ID 01a1a91e-04ba-4526-8946-10483932b30c
Route
oral
Published
Effective Date 2017-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
chlorpheniramine (4 mg)
Inactive Ingredients
silicon dioxide starch, corn fd&c red no. 40 lactose monohydrate magnesium stearate povidone k30 sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance
Imprint: FORTUNE Shape: round Color: red Size: 10 mm Score: 1
Marketing Status
otc monograph drug active Since 2017-09-22

Description

Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg


Medication Information

Warnings and Precautions

Warnings

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis

glaucoma

difficulty in urination due to enlargement of the prostate gland

Active Ingredient

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Indications and Usage

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

sneezing

runny nose

itching of the nose or throat

itchy, watery eyes

Dosage and Administration

Directions

adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor

children under 12 years of age: consult a doctor

Description

Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg

Section 50565-1

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

Section 50567-7

When using this product

do not exceed recommended dosage unless directed by a physician

may cause excitability especially in children

use caution when driving or operating machinery

avoid alcoholic beverages

may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Section 50568-5

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

Section 51727-6

Inactive ingredients

colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate

Section 51945-4

Sprinsol

Safely Sealed

NDC 51467-101-02

Chlorpheniramine maleate - Antihistamine

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

sneezing

runny nose

itching of the nose or throat

itchy, watery eyes

36 Tablets

In Individually Sealed Strip

Respiratory Series

Section 53413-1

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

you may also report serious side effects to this phone number

Section 53414-9

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

Section 55105-1

Purpose

Antihistamine

Section 60561-8

Other information

keep tightly sealed

protect from light

store between 20 to 25 C (68 to 77 F)


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Ask a doctor before use if you have

a breathing problem such as emphysema or chronic bronchitis

glaucoma

difficulty in urination due to enlargement of the prostate gland

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

sneezing

runny nose

itching of the nose or throat

itchy, watery eyes

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor

children under 12 years of age: consult a doctor

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

Section 50567-7 (50567-7)

When using this product

do not exceed recommended dosage unless directed by a physician

may cause excitability especially in children

use caution when driving or operating machinery

avoid alcoholic beverages

may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

Section 51727-6 (51727-6)

Inactive ingredients

colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate

Section 51945-4 (51945-4)

Sprinsol

Safely Sealed

NDC 51467-101-02

Chlorpheniramine maleate - Antihistamine

temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:

sneezing

runny nose

itching of the nose or throat

itchy, watery eyes

36 Tablets

In Individually Sealed Strip

Respiratory Series

Section 53413-1 (53413-1)

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

you may also report serious side effects to this phone number

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 60561-8 (60561-8)

Other information

keep tightly sealed

protect from light

store between 20 to 25 C (68 to 77 F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)