Premier Value Sleep-Aid description, usages, side effects, indications, overdosage, supplying and lots more!

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Premier Value Sleep-Aid

Chain Drug Consortium LLC
Chain Drug Consortium LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

ACTIVE INGREDIENT(S)

Diphenhydramine HCl 50 mg

PURPOSE

Nighttime sleep- aid

USE(S)

  • helps to reduce difficulty falling asleep

WARNINGS

Do not give to children under 12 years of age.

DO NOT USE

  • With other products containing diphenhydramine, even one used on skin.

ASK A DOCTOR BEFORE USE IF

  • emphysema
  • chronic bronchitis
  • glaucoma
  • difficulty in urination due to an enlargement of the prostate gland

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

Sedatives or tranquilizers

WHEN USING THIS PRODUCT

Avoid alcoholic beverages

STOP USE AND ASK DOCTOR IF

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

PREGNANCY/BREASTFEEDING

Ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

In case of accidental 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 over: take 1 softgel at bedtime if needed or as directed by a doctor

STORAGE

  • Store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
  • *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Maximum Strength Unisom SleepGels®

INACTIVE INGREDIENTS

Gelatin, Sorbitol, Sorbitan, FD&C Blue No. 1, Water, Polyethylene Glycol 400, Povidone K-30

PRINCIPAL DISPLAY PANEL

Carton Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


Premier Value Sleep-Aid





Bottle Label PDP

NDC # 68016-302-32

Sleep-Aid
DIPHENHYDRAMINE HCL 50 mg

GET TO SLEEP FAST
SLEEP SOUNDLY
WAKE REFRESHED

32 Softgels


Premier Value Sleep-Aid

Premier Value Sleep-Aid

Diphenhydramine HCL CAPSULE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68016-302
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 50 mg

Inactive Ingredients

Ingredient Name Strength
FD&C BLUE NO. 1
GELATIN
water
SORBITAN
sorbitol
polyethylene glycol 400
POVIDONE K30

Product Characteristics

Color Size Imprint Code Shape
BLUE 13 mm 22 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 32 in 1 BOTTLE
2 NDC:68016-302-32 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-05-31


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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