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topcare nite time

Topco Associates LLC

Topco Associates LLC. Nite Time Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 30 mL dose cup)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose

Cough suppressant

Antihistamine

topcare nite time Uses

temporarily relieves cold symptoms

  • •cough
  • •runny nose and sneezing

Warnings

Do not use

  • •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • •to make a child sleepy

Ask a doctor before use if you have

  • •glaucoma
  • •cough that occurs with too much phlegm (mucus)
  • •a breathing problem such as emphysema or chronic bronchitis
  • •persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • •trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product

  • •do not use more than directed
  • •excitability may occur, especially in children
  • •may cause marked drowsiness
  • •avoid alcoholic drinks
  • •be careful when driving a motor vehicle or operating machinery
  • •alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

  • •cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

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

  • •take only as directed
  • •use dose cup
  • •do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

  • •when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

topcare nite time Other information

  • •each 30 mL dose cup contains: sodium 32 mg
  • • store at 20°-25°C (68°-77°F)

Inactive ingredients

alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-888-423-0139

Principal Display Panel

ALL NIGHT COUGH RELIEF

Nite Time

Cough

Antihistamine - Doxylamine Succinate

Cough Suppressant - Dextromethorphan HBr

CHERRY FLAVOR

COMPARE TO VICKS® NYQUIL® COUGH active ingredients

ALCOHOL 10%

topcare nite time

Dextromethorphan Hydrobromide, Doxylamine Succinate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:36800-668
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 30 mg
DOXYLAMINE SUCCINATE DOXYLAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
ANHYDROUS CITRIC ACID
FD&C BLUE NO. 1
FD&C RED NO. 40
HIGH FRUCTOSE CORN SYRUP
POLYETHYLENE GLYCOLS
propylene glycol
water
SODIUM CITRATE
saccharin sodium

Product Characteristics

Color
RED (Dark Red)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-668-38 296 in 1 BOTTLE
2 NDC:36800-668-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2002-12-10


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Be sure to consult your doctor before taking any medication!
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