SPRINSOL- chlorpheniramine maleate tablet 
FORTUNE PHARMACAL COMPANY LIMITED

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active ingredients (in each tablet)
Chlorpheniramine maleate 4 mg

Purpose
Antihistamine

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

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

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

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

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

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

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
IMAGE OF CARTON

SPRINSOL 
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51467-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE4 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize10mm
FlavorImprint Code FORTUNE
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51467-101-012 in 1 BOX09/22/2017
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:51467-101-023 in 1 BOX09/22/2017
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/22/2017
Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)
Establishment
NameAddressID/FEIBusiness Operations
FORTUNE PHARMACAL COMPANY LIMITED686280561manufacture(51467-101)

Revised: 9/2017
Document Id: b44d3b25-671a-4a8d-87a5-62cd4b71b2a6
Set id: 01a1a91e-04ba-4526-8946-10483932b30c
Version: 1
Effective Time: 20170922
 
FORTUNE PHARMACAL COMPANY LIMITED