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
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 9, 2020
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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 final part341 11/13/2020 Labeler - Walgreen Company (008965063) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(0363-0331)