Allergy Relief by GOODSENSE GDS-1046-2020-0820

Allergy Relief by

Drug Labeling and Warnings

Allergy Relief by is a Otc medication manufactured, distributed, or labeled by GOODSENSE. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY RELIEF- chlorpheniramine maleate tablet, coated 
GOODSENSE

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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GDS-1046-2020-0820

Drug Facts

Active ingredient (in each tablet)	Purpose
Chlorpheniramine maleate 4 mg	Antihistamine

Uses

• temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies:
  • sneezing
  • runny nose
  • itchy, watery eyes
  • itching of the nose or throat

Warnings

Ask a doctor before use if you have

• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate 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 beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• 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 and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours
• children 6 to under 12 years of age: ½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours
• children under 6 years of age: ask a doctor

Other information

• store at 20°-25°C (68°-77°F) in a dry place
• retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, stearic acid

PRINCIPAL DISPLAY PANEL

 GOODSENSE®

NDC: 50804-046-02

4 HOUR

Allergy Relief

Actual Size

Chlorpheniramine Maleate 4mg

Antihistamine

Relief of:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Throat

24 TABLETS

Compare to active ingredient of Chlor-Trimeton® Tablets†

ALLERGY RELIEF 
chlorpheniramine maleate tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-046
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)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
ALUMINUM OXIDE (UNII: LMI26O6933)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	TCL;242
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-046-02	2 in 1 CARTON	06/01/2020	06/30/2022
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 50804-046-03	1 in 1 PACKAGE	06/01/2020	03/31/2022
2		100 in 1 BOTTLE, PLASTIC; 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	06/01/2020	06/30/2022

Labeler - GOODSENSE (076059836)

Revised: 11/2021

Document Id: d09e294e-7065-2bb0-e053-2a95a90a09aa

34390-5

Set id: a126eeaf-d555-7f5d-e053-2a95a90a2d73

Version: 3

Effective Time: 20211112