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

Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine by

Drug Labeling and Warnings

Allergy Relief DIPHENHYDRAMINE HCI, 25 mg Antihistamine by is a Otc medication manufactured, distributed, or labeled by CARDINAL HEALTH, 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.

     very 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:

citric acid, FD&C red #40, flavor, glucose syrup, hydroxypropyl betadex, magnesium stearate, maltitol solution, maltodextrin, neotame, purified water, seaweed extract (carrageenan), sodium chloride, starch, sucralose, sucrose, trisodium citrate dihydrate.

SPL UNCLASSIFIED SECTION

Questions or comments?

Call 1-800-200-6313

Principal display Panel-25 mg carton label

NDC 70000-0590-1

Soft Chews

Allergy Relief DIPHENHYDRAMINE HCI, 25 mg | Antihistamine

Bubble Gum Flavor        Chewy Bites

Allergy Relief for:                    

Sneezing                                            

Runny Nose                                       

Itchy, Watery Eyes                          

Itchy Throat                                      

COMPARE TO BENADRYL ® ALLERGY  active ingredient

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Actual Size         10 PIECES

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0590
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
CORN SYRUP (UNII: 9G5L16BK6N)
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTITOL (UNII: D65DG142WK)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
NEOTAME (UNII: VJ597D52EX)
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	BUBBLE GUM	Imprint Code	o
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0590-1	1 in 1 CARTON	12/06/2021
1		10 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 Drug	M012	12/06/2021

Labeler - CARDINAL HEALTH (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(70000-0590) , pack(70000-0590)