Cough Relief description, usages, side effects, indications, overdosage, supplying and lots more!

Cough Relief

WALGREEN COMPANY

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Walgreen Co. Cough Relief Daytime/Nighttime Cough Relief Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients for Nighttime Cough (in each 30 ml dose cup)

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purpose for Nighttime Cough

Cough suppressant

Antihistamine

Active ingredient for Daytime Cough (in each 15 ml tablespoon)

Dextromethorphan HBr 15 mg

Purpose for Daytime Cough

Cough suppressant

Uses

temporarily relieves:

  • •cough due to minor throat and bronchial irritation
  • •runny nose and sneezing (Nighttime Cough only)

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 these products.
  • •to make a child sleepy (Nighttime Cough only)

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using these products

  • •do not use more than directed

In addition, when using Nighttime Cough:

  • •may cause marked drowsiness
  • •excitability may occur, especially in children
  • •alcohol, sedatives, and tranquilizers may increase drowsiness
  • •be careful when driving a motor vehicle or operating machinery
  • •avoid alcoholic drinks

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 Nighttime Cough or Daytime Cough only as recommended
  • •use dose cup
  • •do not exceed 4 doses per 24 hrs

Nighttime Cough

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

Daytime Cough

adults & children 12 yrs & over

30 ml (2 TBSP) every 6 to 8 hrs

children 6 to under 12 yrs

15 ml (1 TBSP) every 6 to 8 hrs

children 4 to under 6 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

Other information

  • •each 30 ml dose cup of Nighttime Cough contains: sodium 32 mg
  • •each TBSP of Daytime Cough contains: sodium 13 mg
  • •store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime Cough alcohol, anhydrous citric acid, FD&C blue #1, FD&C red #40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime Cough anhydrous citric acid, D&C yellow #10, FD&C yellow #6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments?

1-800-719-9260

Principal Display Panel

COMBO PACK

NON-DROWSY – DAYTIME

Cough Relief

Dextromethorphan HBr / Cough Suppressant

Cough suppressant up to 8 hours

Alcohol free

Antihistamine Free

CITRUS BLEND FLAVOR

COMBO PACK

NIGHTTIME

Cough Relief

Dextromethorphan HBr / Cough Suppressant

Doxylamine Succinate / Sneezing / Runny Nose

Cough suppressant

Antihistamine

10% ALCOHOL

CHERRY FLAVOR

Compare to Vicks® DayQuil® Cough & NyQuil® Cough active ingredients

2 – 12 FL OZ (355 mL) BOTTLES

TOTAL 24 FL OZ (1.5 pt) (710 mL)

Cough Relief

dextromethorphan HBr, doxylamine succinate KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0363-0031
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0363-0031-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2012-09-06


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