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

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

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 55106-9

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

Section 60561-8

Other information

keep tightly sealed

protect from light

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

Structured Label Content

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

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

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 55106-9 (55106-9)

Active ingredients (in each tablet)

Chlorpheniramine maleate 4 mg

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

[{"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LACTOSE MONOHYDRATE", "unii": "EWQ57Q8I5X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"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", "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", "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", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away", "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", "50568-5": "Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers", "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", "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", "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", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Purpose Antihistamine", "55106-9": "Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg", "60561-8": "Other information keep tightly sealed protect from light store between 20 to 25 C (68 to 77 F)"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information