Nighttime Allergy Relief by MEIJER, INC. Drug Facts

Nighttime Allergy Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

NIGHTTIME ALLERGY RELIEF EXTRA STRENGTH- diphenhydramine hcl tablet 
MEIJER, INC.

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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Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid/Antihistamine

Uses

• helps to reduce difficulty falling asleep
• 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

Warnings

Do not use

• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers.

When using this product

• marked drowsiness will 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

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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 of age and older
  • take 1 caplet  (50 mg) at bedtime
• children under the age of 12 years: do not use

Other information

• each tablet contains: calcium 35 mg
• store at 15°-30°C (59°-86°F)

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, stearic acid

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to Benadryl® Allergy Nighttime active ingredient*

Extra Strength

Nighttime Allergy Relief

Diphenhydramine HCl, 50 mg

Nighttime Sleep-Aid / Antihistamine

Effective Relief from:

Sneezing

Runny Nose

Itchy, Watery Eyes

Itchy Nose or Throat

Caplets  50 mg each 

DIST. BY MEIJER DISTRIBUTION, INC.

GRAND RAPIDS,MI 49544

www.meijer.com

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Product Label

Meijer Extra Strength Nighttime Allergy Relief

NIGHTTIME ALLERGY RELIEF  EXTRA STRENGTH
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41250-266
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)

Product Characteristics
Color	BLUE	Score	no score
Shape	CAPSULE	Size	14mm
Flavor		Imprint Code	TCL350
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41250-266-24	24 in 1 CARTON	06/30/2014	12/31/2019
1		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part338	06/30/2014	12/31/2019

Labeler - MEIJER, INC. (006959555)

Revised: 12/2018

Document Id: a0958e03-07e2-4cdf-adf5-2283789f54b1

34390-5

Set id: 2ffc5822-e0a3-4ff7-904c-c38eb0ef0b6e

Version: 3

Effective Time: 20181218

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