allergy relief by Allwell Health Inc / LNK International, Inc. AllWell Health 44-614

allergy relief by

Drug Labeling and Warnings

allergy relief by is a Otc medication manufactured, distributed, or labeled by Allwell Health Inc, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALLERGY RELIEF- diphenhydramine hcl tablet, film coated 
Allwell Health Inc

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AllWell Health 44-614

Active ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not use

• to make a 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
• 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

• marked drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives, and tranquilizers may increase drowsiness
• use caution 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 right away.

Directions

• take every 4 to 6 hours, or as directed by a doctor
• do not take more than 6 times in 24 hours

• adults and children 12 years and over: 1 to 2 tablets
• children 6 to under 12 years: 1 tablet
• children under 6 years: do not use

Other information

• each tablet contains: calcium 30 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture
• use by expiration date on package
  

Inactive ingredients

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

Questions or comments?

1-800-426-9391

Principal display panel

allwell™

NDC: 80539-614-03

allergy relief

diphenhydramine HCl, 25 mg
antihistamine

10 tablets / actual size

TAMPER EVIDENT: DO NOT USE
IF PRINTED TEAR STRIP IS
BROKEN OR MISSING

distributed by:
AllWell Health, Inc.
Princeton, NJ 08540

50844      ORG041961403

AllWell Health 44-614

ALLERGY RELIEF 
diphenhydramine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80539-614
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
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;614
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80539-614-03	10 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2021	03/22/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	03/15/2021	03/22/2024

Labeler - Allwell Health Inc (117644800)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	pack(80539-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(80539-614) , pack(80539-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(80539-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	manufacture(80539-614)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	pack(80539-614)

Revised: 3/2024

Document Id: fa2f81e3-631c-4d25-ac45-1b0b4de18026

34390-5

Set id: d73f85d4-a8d5-4ce9-9024-a9702b351e22

Version: 6

Effective Time: 20240322