Label: NIGHT TIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquid
- NDC Code(s): 0363-0331-26
- Packager: Walgreen Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 daily while
using this product. -
DO NOT USE
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 sleep. -
OTHER SAFETY INFORMATION
Ask a doctor before use if you have ■ a sodium
restricted diet. liver disease ■ heart disease ■
glaucoma ■ high blood pressure ■ thyroid disease
■ diabetes. 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 DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if ■ you get nervous, dizzy or sleepless ■ redness
or swelling is present ■ pain, nasal congestion, or cough gets worse or lasts more
than 7 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur
■ cough comes back or occurs with rash or headache that lasts. These could be
signs of a serious condition. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
■ take only as recommended. See Warnings
■ use dose cup or tablespoon (TBSP)
■ do not exceed 4 doses per 24 hours
Age Dose Adults & children 12 years & over 30 mL (2 TBSP) every 4 hours Children 4 to under 12 years Ask a doctor Children under 4 years Do not use ■ do not exceed 4 doses per 24 hours
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Product Label
Walgreens
Compare to Vicks® NyQuil™
Severe Nighttime Cold &
Flu Relief active ingredients††NDC 0363-0331-26
NIGHTTIME
Severe Cold & Flu
ACETAMINOPHEN / FEVER REDUCER
DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT
DOXYLAMINE SUCCINATE / ANTIHISTAMINE
PHENYLPHRINE HCl / NASAL DECONGESTANTAMAXIMUM STRENGTH
• Pain reliever, fever reducer,
cough suppressant, antihistamine
& nasal decongestantORIGINAL
FLAVOR
8 FL OZ (237 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR TORN
DISTRIBUTED BY WALGREEN CO., 200 WILMONT RD., DEERFIELD, IL 60015
100 % SATISFACTION GUARANTEED walgreens.com@2020WalgreenVo.
LR-151
ORG1020-F
res
-
INGREDIENTS AND APPEARANCE
NIGHT TIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0331 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color green (Original Cough Syrup Flavor) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0331-26 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/13/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 11/13/2020 Labeler - Walgreen Company (008965063) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(0363-0331)