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Walgreen Nighttime Cold and Flu Relief

Dosage form: liquid
Ingredients: ACETAMINOPHEN 500mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL
Labeler: Walgreen Company
NDC code: 0363-0041

Walgreen Co. Nighttime Cold and Flu Relief Liquid Drug Facts

Active ingredient (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

more than 4 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, persists for more than two days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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

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

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers
taking the blood thinning drug warfarin

When using this product

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

pain or cough gets worse or lasts more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur
cough comes back or occurs with 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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take only as recommended – see Liver warning
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 18 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}?

Principal Display Panel

Compare to Vicks® NyQuil® active ingredients

See New Warnings Information

Multi-Symptom

NightTime

Cold & Flu Relief

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Doxylamine succinate - Sneezing, Runny Nose

Cherry Flavor

10% Alcohol

Product Label

WALGREEN NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide and doxylamine succinate liquid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0363-0041
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (ACETAMINOPHEN)	ACETAMINOPHEN	500 mg in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE)	DOXYLAMINE SUCCINATE	6.25 mg in 15 mL

Product Characteristics
Color	RED (Clear Dark)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:0363-0041-30	177 mL in 1 BOTTLE
2	NDC:0363-0041-38	296 mL in 1 BOTTLE
3	NDC:0363-0041-43	473 mL in 1 BOTTLE
4	NDC:0363-0041-33	590 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/09/2009

Labeler - Walgreen Company (008965063)

Revised: 07/2009

Document Id: e77ae2d7-7331-4492-9e78-8eb4b2a9bc4e

Set id: ee4b1013-0e02-45ce-88cd-7fb58aa68ebe

Version: 1

Effective Time: 20090709

Walgreen Company

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer