SPRINSOL- chlorpheniramine maleate tablet

SPRINSOL by

Drug Labeling and Warnings

SPRINSOL by is a Otc medication manufactured, distributed, or labeled by FORTUNE PHARMACAL COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients (in each tablet)
Chlorpheniramine maleate 4 mg

PURPOSE

Purpose
Antihistamine

INDICATIONS & 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

WARNINGS

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

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers

WHEN USING

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

PREGNANCY 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

DOSAGE & 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

OTHER SAFETY INFORMATION

Other information
keep tightly sealed
protect from light
store between 20 to 25 C (68 to 77 F)

INACTIVE INGREDIENT

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

QUESTIONS

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm
you may also report serious side effects to this phone number

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

SPRINSOL 
chlorpheniramine maleate tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	FORTUNE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-101-01	2 in 1 BOX	09/22/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51467-101-02	3 in 1 BOX	09/22/2017
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/22/2017

Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY LIMITED		686280561	manufacture(51467-101)