NIGHTTIME- diphenhydramine hydrochloride tablet
Western Family Foods 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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Western Family NightTime Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 25 mg

Purpose

Nighttime sleep-aid

Uses

for relief of occasional sleeplessness

Warnings

Do not use

•: in 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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

avoid alcoholic drinks

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of 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 and over

take 2 caplets at bedtime if needed or as directed by a doctor

children under 12 years

do not use

Other information

•: each caplet contains: calcium 15 mg
•: store at 20-25°C (68-77°F)

Inactive ingredients

carnauba wax, crospovidone, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid, titanium dioxide

Principal Display Panel

For a Restful Night's Sleep

NightTime

Diphenhydramine HCl 25 mg - Sleep Aid

Gluten Free

Nighttime Sleep Aid

Non Habit-forming

Contains No Pain Reliever

COMPARE TO ACTIVE INGREDIENT OF SIMPLY SLEEP® NIGHTTIME SLEEP AID

NightTime Carton Image 1

NightTime Carton Image 2

NIGHTTIME
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55312-431
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
CARNAUBA WAX (UNII: R12CBM0EIZ)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE (Light Blue)	Score	no score
Shape	CAPSULE	Size	11mm
Flavor		Imprint Code	L431
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55312-431-62	2 in 1 CARTON	01/28/2001	08/31/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part338	01/28/2001	08/31/2017

Labeler - Western Family Foods Inc (192166072)

Revised: 11/2017

Document Id: fcd86a7c-25cc-4476-9dcb-c719f1aae9ba

Set id: 6353fa3f-1949-4593-81df-4b57b26f3c83

Version: 2

Effective Time: 20171127

Western Family Foods Inc