Label: NIGHTTIME COUGH- dextromethorphan hydrobromide and doxylamine succinate liquid
- NDC Code(s): 0363-0668-30, 0363-0668-38
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient (in each 15 mL tablespoon)
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mgClose
temporarily relieves cold symptoms:
- runny nose and sneezing
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
- 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
When using this product
- do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- 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 for 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
- take only as recommended
- use dose cup
- do not exceed 4 doses per 24 hours
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
- when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
- Other information
- each TBSP contains: sodium 15 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 citrateClose
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Compare to NyQuil® Cough active ingredients
See Labeling Changes
All Night Cough Relief
Cough Suppressant, Antihistamine
Dextromethorphan HBr – Cough
Doxylamine Succinate – Sneezing, Runny Nose
- INGREDIENTS AND APPEARANCE
dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-0668 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 15 mL DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL 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 SACCHARIN SODIUM SODIUM CITRATE Product Characteristics Color RED (Dark Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0668-30 177 mL in 1 BOTTLE 2 NDC:0363-0668-38 296 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/16/2002 Labeler - Walgreen Company (008965063)