TELDRIN ALLERGY RELIEF- chlorpheniramine maleate tablet 
Gemini Pharmaceuticals, Inc.

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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Teldrin HBP Tablets

Active Ingredients (in each tablet)

Chlorpheniramine Maleate 4mg

Purpose

Antihistamine

Uses

For temporary relief of:

  • runny nose
  • sneezing
  • itching of the nose and throat
  • itchy, watery eyes due to hay fever or other upper respiratory allergies.

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 prostrate gland

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

When using this product

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

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. (1-800-222-1222)

Directions

Adults and children 12 years of age and overTake 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours, or as directed by a doctor
Children 6 to under 12 years of agetake 1/2 tablet every 4-6 hours, not to exceed 3 tablets in 24 hours, or as directed by a doctor
Children under 6 years of ageconsult a doctor

Other information

  • Store at room temperature
  • Retain carton for complete product information

Inactive ingredients

Dicalcium Phosphate Dihydrate, D&C Yellow # 10, Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Pregelatinized Corn Starch, Silicon Dioxide, Stearic Acid

Questions or comments?

If you have any questions or comments, or to report an adverse event, please contact 1-888-876-6898

Package label Sine Off Maximum Strength

Teldrin ®

Decongestant - Free
Allergy Relief
HBP for people with High Blood Pressure

Chlorpheniramine Maleate 4 mg Each

Antihistamine
24 Tablet Teldrin Allergy Relief 24 Count Label




TELDRIN  ALLERGY RELIEF
chlorpheniramine maleate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51645-826
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColoryellowScore2 pieces
ShapeROUND (Round Biconvex) Size8mm
FlavorImprint Code GPIP60
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51645-826-241 in 1 BOX07/05/201211/30/2017
124 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/201011/30/2017
Labeler - Gemini Pharmaceuticals, Inc. (055942270)
Establishment
NameAddressID/FEIBusiness Operations
Gemini Pharmaceuticals, Inc.055942270manufacture(51645-826)

Revised: 11/2017
Document Id: 5df4e8e0-4bec-7690-e053-2a91aa0aa076
Set id: 4cdbecbe-3219-4083-adc0-5479dc3ad3b9
Version: 2
Effective Time: 20171114
 
Gemini Pharmaceuticals, Inc.