Label: NITE TIME SEVERE COLD AND FLU MAXIMUM STRENGTH- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated
- NDC Code(s): 41250-877-08
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
-
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- sinus congestion and pressure
- sore throat
- fever
- headache
- nasal congestion
- cough to help you sleep
- cough due to minor throat and bronchial irritation
- runny nose and sneezing
- promotes nasal and/or sinus drainage
- temporarily restores freer breathing through the nose
- reduces swelling of nasal passages
- temporarily relieves common cold and flu symptoms:
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- diabetes
- thyroid disease
- heart disease
- glaucoma
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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.
- Directions
- Other information
-
Inactive ingredients
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
- Questions or comments?
-
Principal Display Panel
NDC 41250-877-08
meijer®
Compare to
Vicks® NyQuil® VapoCOOL®
SEVERE COLD & FLU
+ CONGESTION
active ingredients*MAXIMUM STRENGTH
nitetime
severe
cold & fluAcetaminophen | Pain Reliever | Fever Reducer
Dextromethorphan HBr | Cough Suppressant
Doxylamine Succinate | Antihistamine
Phenylephrine HCl | Nasal DecongestantRelieves: Headache, Fever, Sore Throat, Minor Aches & Pains,
Nasal/Sinus Congestion & Sinus Pressure, Sneezing, Runny Nose, Cough24 Caplets
Actual
SizeTAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING*This product is not manufactured or distributed by The Procter & Gamble Company,
owner of the registered trademark Vicks® NyQuil® VapoCOOL® SEVERE COLD & FLU
+ CONGESTION. 50844 REV0722D67708DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.comOUR QUALITY GUARANTEE
The Meijer Family
WWW.MEIJER.COM/SATISFACTIONPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Meijer 44-677
-
INGREDIENTS AND APPEARANCE
NITE TIME SEVERE COLD AND FLU MAXIMUM STRENGTH
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-877 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;677 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-877-08 2 in 1 CARTON 08/01/2015 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/01/2015 Labeler - Meijer Distribution Inc (006959555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(41250-877) , pack(41250-877) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(41250-877) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(41250-877) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(41250-877)