Label: MEIJER NITETIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate solution
- NDC Code(s): 79481-6921-2
- Packager: MEIJER DISTRIBUTION INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 April 19, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (in each 30 mL)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4 doses in 24 hours, which is the maximum daily amount for this product
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- Skin reddening
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- Blisters
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- Rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
Ask a doctor before use if you have
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- liver disease
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem or chronic cough as occurs with smoking, asthma, or emphysema
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- trouble urinating due to an enlarged prostate gland
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- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
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- taking sedatives or tranquilizers
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- taking the blood thinning drug warfarin
- Directions
- Other information
- Inactive ingredients
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Package/Label Principal Display Panel
Compare to the active ingredients in VICKS® Nyquil™COLD & FLU NIGHTTIME RELIEF*
Nitetime
Cold & Flu
Relief
PAIN RELIEVER/FEVER REDUCER, COUGH SUPPRESSANT
ANTIHISTAMINE
Acetaminophen,
Dextromethorphan HBr,
Doxylamine Succinate
RELIEVES: HEADACHE, FEVER, SORE THROAT
MINOR ACHES & PAINS
SNEEZING, RUNNY NOSE, COUGH
Mixed Berry
Naturally and Artificially Flavored
12 FL OZ (354 mL)
DIST. BY
MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
*This product is not manufactured or distributed by Procter & Gamble, the distributor of Vicks® Nyquil™COLD & FLU Nighttime Relief*
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INGREDIENTS AND APPEARANCE
MEIJER NITETIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-6921 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 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYL GALLATE (UNII: 8D4SNN7V92) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color RED (clear dark red) Score Shape Size Flavor BERRY (Mixed Berry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79481-6921-2 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/31/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/31/2023 Labeler - MEIJER DISTRIBUTION INC (006959555)