ALLERGY RELIEF DIPHENHYDRAMINE HCL 25 MG ANTIHISTAMINE- diphenhydramine hcl bar, chewable

Allergy Relief Diphenhydramine HCl 25 mg ANTIHISTAMINE by

Drug Labeling and Warnings

Allergy Relief Diphenhydramine HCl 25 mg ANTIHISTAMINE by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each piece)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

• To make child sleepy
• with any other product containing diphenhydramine, even one used on skin

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

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
• 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 (1-800-222-1222) right away. 

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hour                                                                                                                                                  
  • Age (yr):

    Dose (Piece)

  • Adults and children 12 years and over:

    1 to 2 Pieces (25 mg to 50 mg)

  • Children 6 to 11 years:

    1 Piece (25 mg)

  • Children under 6 years:

    Do not use

SPL UNCLASSIFIED SECTION

Other information

• each piece: contains sodium 9 mg.

     Low sodium

• store in a cool dry place between 20-25°C (68-77°F).
• Child Resistant Container;do not use if printed seal under cap is broken or missing.

Inactive ingredients:

FD&C Red# 40, flavors, geleol mono and diglycerides, glucose syrup, gum arabic, hydroxypropyl betadex, maltitol solution, neotame, polyethylene glycol 400, povidone K30, propylene glycol, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 833-358-6431
Monday to Friday 9:00am to 7:00pm EST

Principal display Panel-25 mg Bottle label

NDC: 70677-1059-1     COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL ® ALLERGY *

Foster & Thrive TM

ALLERGY RELIEF

Diphenhydramine HCl

25 mg 

Antihistamine

Mixed Berry Flavor       

Gummy Bite       

For relief of:

• Sneezing
• Runny nose
• Itchy, Watery eyes & Itchy Throat

ACTUAL SIZE

20 PIECES

INGREDIENTS AND APPEARANCE

ALLERGY RELIEF DIPHENHYDRAMINE HCL 25 MG ANTIHISTAMINE 
diphenhydramine hcl bar, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1059
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
CORN SYRUP (UNII: 9G5L16BK6N)
ACACIA (UNII: 5C5403N26O)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)
MALTITOL (UNII: D65DG142WK)
NEOTAME (UNII: VJ597D52EX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
STARCH, CORN (UNII: O8232NY3SJ)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Product Characteristics
Color	pink (Light pink to red pink)	Score	no score
Shape	RECTANGLE	Size	23mm
Flavor	BERRY (Mixed Berry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70677-1059-1	20 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/27/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(70677-1059)