Foster And Thrive 44-194

SPL v1

SPL

SPL Set ID ee052b39-1658-4071-b081-5433c87b5e4a

Route

ORAL

Published

Effective Date 2011-12-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Chlorpheniramine (4 mg)

Inactive Ingredients

Starch, Corn D&c Yellow No. 10 Aluminum Lake Anhydrous Lactose Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance

Imprint: 44;194 Shape: round Color: yellow Size: 8 mm Score: 2

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-04-22

Description

Chlorpheniramine maleate 4 mg

Purpose

Antihistamine

How Supplied

Chlorpheniramine maleate 4 mg: color yellow, score 2, shape round and the imprint code 44;194. NDC: 71335-2812-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-2: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-3: 100 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-4: 120 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-5: 40 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-6: 24 Tablets in a BOTTLE, PLASTIC Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF). protect from excessive moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Medication Information

Purpose

Antihistamine

How Supplied

Chlorpheniramine maleate 4 mg: color yellow, score 2, shape round and the imprint code 44;194.

NDC: 71335-2812-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-2: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-3: 100 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-4: 120 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-5: 40 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-6: 24 Tablets in a BOTTLE, PLASTIC

Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF).

protect from excessive moisture.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Description

Chlorpheniramine maleate 4 mg

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

Section 51945-4

Chlorpheniramine Maleate 4 mg Tablet

Directions

take every 4 to 6 hours, or as directed by a doctor

adults and children 12 years and over	1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years	1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years	do not use

Do Not Use

to make a child sleepy.

Other Information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from excessive moisture
see end flap for expiration date and lot number

Inactive Ingredients

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions Or Comments?

Call 833-358-6431

Monday to Friday 9:00am to 7:00pm EST

When Using This Product

drowsiness may occur
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children

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.

Active Ingredient (in Each Tablet)

Chlorpheniramine maleate 4 mg

Ask A Doctor Before Use If You Have

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking sedatives or tranquilizers.

Structured Label Content

Uses

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

sneezing
runny nose
itchy, watery eyes
itching of the nose or throat

Section 51945-4 (51945-4)

Chlorpheniramine Maleate 4 mg Tablet

Purpose

Antihistamine

Directions

take every 4 to 6 hours, or as directed by a doctor

adults and children 12 years and over	1 tablet. Do not exceed 6 tablets in 24 hours.
children 6 to under 12 years	1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours.
children under 6 years	do not use

Do Not Use (Do not use)

to make a child sleepy.

How Supplied (HOW SUPPLIED)

Chlorpheniramine maleate 4 mg: color yellow, score 2, shape round and the imprint code 44;194.

NDC: 71335-2812-1: 30 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-2: 60 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-3: 100 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-4: 120 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-5: 40 Tablets in a BOTTLE, PLASTIC

NDC: 71335-2812-6: 24 Tablets in a BOTTLE, PLASTIC

Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF).

protect from excessive moisture.

Repackaged/Relabeled by:

Bryant Ranch Prepack, Inc.

Burbank, CA 91504

Other Information (Other information)

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
protect from excessive moisture
see end flap for expiration date and lot number

Inactive Ingredients (Inactive ingredients)

corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose

Questions Or Comments? (Questions or comments?)

Call 833-358-6431

Monday to Friday 9:00am to 7:00pm EST

When Using This Product (When using this product)

drowsiness may occur
avoid alcoholic beverages
use caution when driving a motor vehicle or operating machinery
alcohol, sedatives, and tranquilizers may increase drowsiness
excitability may occur, especially in children

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Chlorpheniramine maleate 4 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

glaucoma
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10 ALUMINUM LAKE", "unii": "CQ3XH3DET6", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing runny nose itchy, watery eyes itching of the nose or throat", "51945-4": "Chlorpheniramine Maleate 4 mg Tablet", "Purpose": "Antihistamine", "Directions": "take every 4 to 6 hours, or as directed by a doctor adults and children 12 years and over 1 tablet. Do not exceed 6 tablets in 24 hours. children 6 to under 12 years 1/2 tablet (break tablet in half). Do not exceed 3 whole tablets in 24 hours. children under 6 years do not use", "Do not use": "to make a child sleepy.", "HOW SUPPLIED": "Chlorpheniramine maleate 4 mg: color yellow, score 2, shape round and the imprint code 44;194. NDC: 71335-2812-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-2: 60 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-3: 100 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-4: 120 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-5: 40 Tablets in a BOTTLE, PLASTIC NDC: 71335-2812-6: 24 Tablets in a BOTTLE, PLASTIC Store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF). protect from excessive moisture. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504", "Other information": "store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) protect from excessive moisture see end flap for expiration date and lot number", "Inactive ingredients": "corn starch, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose", "Questions or comments?": "Call 833-358-6431 Monday to Friday 9:00am to 7:00pm EST", "When using this product": "drowsiness may occur avoid alcoholic beverages use caution when driving a motor vehicle or operating machinery alcohol, sedatives, and tranquilizers may increase drowsiness excitability may occur, especially in children", "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.", "Active ingredient (in each tablet)": "Chlorpheniramine maleate 4 mg", "Ask a doctor before use if you have": "glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking sedatives or tranquilizers."}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:43.006435 · Updated: 2026-03-14T23:13:05.198485