DailyMed - ALLERGY RELIEF- diphenhydramine hci tablet, film coated

NDC Code(s): 49035-164-12
Packager: Wal-Mart Stores Inc

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated May 28, 2025

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Active ingredient (in each tablet)
Diphenhydramine HCl 25 mg

Diphenhydramine HCl 25 mg
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Purpose
Antihistamine

Antihistamine
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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 ...
- 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
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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 ...
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
- difficulty in urination due to enlargement of the prostate gland
- glaucoma
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.

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Directions
do not take more than directed - 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 over1 to 2 tablets - children ...
- do not take more than directed
- 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

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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 - see end flap for expiration date and lot number
- each tablet contains: calcium 30 mg
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- protect from moisture
- see end flap for expiration date and lot number
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Inactive ingredients
corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc

corn starch, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc
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Questions or comments?
1-888-287-1915

1-888-287-1915
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Principal display panel
equate™ NDC 49035-164-12 - Compare to Benadryl® Allergy Ultratabs® Active Ingredient* Dye Free - Allergy Relief - Diphenhydramine HCI, 25 mg - Antihistamine - Allergy relief for: • Sneezing        ...

equate™

NDC 49035-164-12

Compare to Benadryl® Allergy Ultratabs® Active Ingredient*

Dye Free
Allergy Relief
Diphenhydramine HCI, 25 mg
Antihistamine

Allergy relief for:
• Sneezing        • Itchy, watery eyes
• Runny nose    • Itchy throat

25
mg
EACH

100
TABLETS

Actual Size

TAMPER EVIDENT: DO NOT USE IF
IMPRINTED SAFETY SEAL UNDER
CAP IS BROKEN OR MISSING

Satisfaction guaranteed – For questions
or comments please call 1-888-287-1915.

DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716

PRODUCT OF CHINA

*This product is not manufactured or
distributed by Johnson & Johnson
Corporation, owner of the registered
trademark Benadryl® Allergy Ultratabs®.
50844 REV0422B61412

Equate 44-614

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INGREDIENTS AND APPEARANCE

Product Information

ALLERGY RELIEF diphenhydramine hci tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:49035-164
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:49035-164-12	1 in 1 CARTON	08/15/2018	07/31/2026
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M012	08/15/2018	07/31/2026

Labeler - Wal-Mart Stores Inc (051957769)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		038154464	pack(49035-164)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867837	manufacture(49035-164) , pack(49035-164)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		832867894	manufacture(49035-164)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		868734088	manufacture(49035-164)

Name	Address	ID/FEI	Business Operations
Establishment
LNK International, Inc.		967626305	pack(49035-164)

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Published Date (What is this?)	Version	Files
May 30, 2025	12 (current)	download
Jul 15, 2024	11	download
Oct 9, 2023	10	download
Jul 26, 2023	9	download
Jul 13, 2022	8	download
Jun 20, 2022	7	download
Jun 8, 2021	6	download
Jun 17, 2020	5	download
May 21, 2020	3	download
May 13, 2019	2	download
Aug 15, 2018	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
2	1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD

Label: ALLERGY RELIEF- diphenhydramine hci tablet, film coated

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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

Label: ALLERGY RELIEF- diphenhydramine hci tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Do not use

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

ALLERGY RELIEF- diphenhydramine hci tablet, film coated

Number of versions: 11

ALLERGY RELIEF- diphenhydramine hci tablet, film coated

ALLERGY RELIEF- diphenhydramine hci tablet, film coated

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ALLERGY RELIEF- diphenhydramine hci tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.