SPL v6
SPL
SPL Set ID 3baea6f7-9524-46e8-ba82-8892f0842278
Route
ORAL
Published
Effective Date 2023-12-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 4 Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-10-27
Description

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Purpose

Cough suppressant Antihistamine

Medication Information

Purpose

Cough suppressant

Antihistamine

Description

Dextromethorphan HBr 30 mg Doxylamine Succinate 12.5 mg

Uses

temporarily relieves cold symptoms:

  • runny nose and sneezing
  • cough
Warnings

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Directions
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • When using Day Time and Night Time products, carefully read each label to ensure
 adults and children 12 years and over  30 mL (2 TBSP) every 6 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  do not use

Do Not Use
  • if you are now taking a prescription monamine 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
Drug Facts

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Questions ?

Call weekdays from 9:30 am to 4:30 pm EST.

1-877-798-5944.

Other Information
  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature
Discount Drug Mart

*COMPARE TO THE INGREDIENTS IN VICKS® NYQUIL® COUGH

DISCOUNT

drug mart

FOOD FAIR

Cherry

Night-Time

COUGH RELIEF

Dextromethorphan HBr ..... Cough Suppressant

Doxylamine Succiate ......... Antihistamine

  • Cough
  • Sneezing
  • Runny Nose

12 FL OZ (354 mL)

* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil® Cough

LR-067

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION ,  NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

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Inactive Ingredients

citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • 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.
Keep Out of Reach of Children

Keep out of reach of children.

If Pregnant Or Breast Feeding,

ask a health professionalbefore use.

Ask A Doctor Befor Use If You Have
  • a sodium restricted diet
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use
  • if you are taking sedatives or tranquilizers

Structured Label Content

Uses

temporarily relieves cold symptoms:

  • runny nose and sneezing
  • cough
Purpose

Cough suppressant

Antihistamine

Warnings

DO NOT USE IF IMPRINTED SHRINK BRAND IS MISSING OR BROKEN

Failure to follow these warnings could result in serious consequences.

Directions
  • Use dose cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours
  • When using Day Time and Night Time products, carefully read each label to ensure
 adults and children 12 years and over  30 mL (2 TBSP) every 6 hours
 children 4 to under 12 years  ask a doctor
 children under 4 years  do not use

Do Not Use (Do not use)
  • if you are now taking a prescription monamine 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
Drug Facts

Dextromethorphan HBr 30 mg

Doxylamine Succinate 12.5 mg

Questions ?

Call weekdays from 9:30 am to 4:30 pm EST.

1-877-798-5944.

Other Information (Other information)
  • each 30 mL dose cup contains: sodium 45 mg
  • store at room temperature
Discount Drug Mart (DISCOUNT drug mart)

*COMPARE TO THE INGREDIENTS IN VICKS® NYQUIL® COUGH

DISCOUNT

drug mart

FOOD FAIR

Cherry

Night-Time

COUGH RELIEF

Dextromethorphan HBr ..... Cough Suppressant

Doxylamine Succiate ......... Antihistamine

  • Cough
  • Sneezing
  • Runny Nose

12 FL OZ (354 mL)

* This product is not manufactured or distributed by Proctor and Gamble owner of the registered trademark Vicks® Nyquil® Cough

LR-067

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO THE STORE, SEND REASON FOR DISSATISFACTION ,  NAME, ADDRESS AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE MEDINNA, OHIO 44256

res

Inactive Ingredients (Inactive ingredients)

citric acid, FD and C Blue No. 1, FD and C Red No. 40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sucrose

When Using This Product (When using this product)
  • do not use more than directed
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness
Stop Use and Ask A Doctor If (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.
Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children.

If Pregnant Or Breast Feeding, (If pregnant or breast feeding,)

ask a health professionalbefore use.

Ask A Doctor Befor Use If You Have (Ask a doctor befor use if you have)
  • a sodium restricted diet
  • glaucoma
  • 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
  • trouble urinating due to enlarged prostate gland
Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)
  • if you are taking sedatives or tranquilizers

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:53.429678 · Updated: 2026-03-14T23:11:51.346073