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Nytol

GlaxoSmithKline Consumer Healthcare LP

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Diphenhydramine HCl 25 mg

Nighttime sleep-aid

relieves occasional sleeplessness

Do not use

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

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • •avoid alcoholic beverages
  • •be careful when driving a motor vehicle or operating machinery

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.

adults and children 12 years of age and over: take 2 caplets at bedtime if needed, or as directed by a doctor

  • each caplet contains: calcium 70mg
  • •store below 25°C (77°F)

carnauba wax, dibasic calcium phosphate, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, starch

1-866-255-5203 (English/Spanish) weekdays

Principal Display Panel

NDC 10158-043-02

Nytol ®

QuickCaps ®

with Diphenhydramine HCl

NIGHTTIME SLEEP-AID

Easy to Swallow Caplets

Helps you fall asleep FAST!

16 CAPLETS

Nytol

diphenhydramine HCl TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10158-043
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 25 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol 400
POLYETHYLENE GLYCOL 8000
SILICON DIOXIDE
STARCH, CORN

Product Characteristics

Color Size Imprint Code Shape
WHITE 14 mm N OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 8 in 1 BLISTER PACK
2 8 in 1 BLISTER PACK
3 NDC:10158-043-04 4 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part338 2011-08-12


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Be sure to consult your doctor before taking any medication!
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