Daytime and nighttime cough relief kit

Drug facts - day time

Active ingredients (in each10 mL)

Dextromethorphan HBr, USP 20 mg
Guaifenesin, USP 400 mg

Drug facts - night time

Active ingredients (in each10 mL)

Dextromethorphan HBr, USP 30 mg
Doxylamine Succinate, USP 12.5 mg

Purposes - day time

Cough suppressant
Expectorant

Purposes - night time

Cough suppressant

Antihistamine

Uses - day time

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Uses - night time

  • temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itching of the nose or throat
  • controls the impulse to cough to help you sleep

Warnings - day time

Do not useif 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.

Warnings - night time

Do not use

  • to sedate a child or to make a child sleepy
  • 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.

Ask a doctor before use if you have - day time

  • cough that occurs with too much phlegm(mucus)
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor before use if you have - night time

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

Ask a doctor or pharmacist before use if you are - night time

taking sedatives or tranquilizers

When using this product - night time

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

Stop use and ask a doctor if - day time

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.

Stop use and ask a doctor if - night time

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

If pregnant or breast-feeding, - day time

ask a health professional before use.

If pregnant or breast-feeding, - night time

ask a health professional before use.

Keep out of reach of children. - day time

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Keep out of reach of children. - night time

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions -day time

  • shake well before using
  • do not take more than 6 doses (12 tsp) in any 24-hour period
  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • this adult product is not intended for use in children under 12 years of age
Age
Dose
adults and children 12 years and over
10 mL every 4 hours
children under 12 years
do not use

Directions -night time

  • measure only with dosing cup provided
  • keep dosing cup with product
  • mL = milliliter
  • do not take more than 4 doses (8 tsp) in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
  • shake well before using
age
dose
adults and children 12 years and over
10 mL every 6 hours
children under 12 years
do not use

Other information -day time

  • each 10 mL contains:sodium 8 mg
  • store at 20-25C (68-77F). Do not refrigerate
  • alcohol-free

Other information -night time

  • each 10 mL contains:sodium 7 mg
  • store at 20-25C (68-77F).
  • alcohol-free

Inactive ingredients -day time

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C red #40, flavors, glycerin, high fructose corn syrup, menthol, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Inactive ingredients - night time

anhydrous citric acid, FD&C red # 40, flavors, glycerin, high fructose corn syrup, menthol, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sucralose, xanthan gum

Questions or comments?

1-855-274-4122

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2016 CVS/pharmacy
CVS.com 1-800-SHOP CVS
V-32402

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Ingredients and appearance - Product information

Daytime and nighttime cough relief kit- Dextromethorphan hbr, guaifenesin, dextromethorphan hbr, doxylamine succinate

Product information

Product Type Human OTC Drug Label Item Code (Source) NDC: 69842-009
Route of Administration Oral

Product Characteristics

Color RED (a clear red colored liquid) Flavor PINEAPPLE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC MONOGRAPH FINAL part341 USA 2016/05/02

Labeler - CVS Pharmacy, Inc.( 062312574)

Establishment

Name ID/FEI Business Operations
CVS Pharmacy, Inc. 062312574 MANUFACTURE( 69842-009)

Package label-principal display panel 8 fl oz (236 ml bottle)

Compare to the active ingredients in Adult
Robitussin ®Peak Cold Maximum Strength Cough + Chest Congestion DM *

MAXIMUM STRENGTH
FOR MUCUS RELIEF
Non-Drowsy
Tussin DM
DEXTROMETHORPHAN HBr, 20mg
Cough suppressant

GUAIFENESIN, USP 400 mg
Expectorant

Adult Cough &
Chest Congestion
Relieves:

  • Cough
  • Chest congestion/mucus

Alcohol free

Cherry Flavor
Liquid

For Ages 12 & Over

Compare to the active ingredients in Adult Robitussin ®Maximum
Strength Nighttime Cough DM *

MAXIMUM STRENGTH
Nighttime
Tussin DM

DEXTROMETHORPHAN HBr, 30 mg
Cough suppressant

DOXYLAMINE SUCCINATE 12.5 mg
Antihistamine

Adult Cough
& Antihistamine

Relieves:

  • Cough
  • Itchy throat
  • Runny nose

Alcohol free

Pineapple Flavor
Liquid

For Ages 12 & Over

4 FL OZ (118 mL) + 4 FL OZ (118 mL)
TOTAL 8 FL OZ (236 mL)