MAJOR NIGHT TIME MULTI SYMPTOM COLD AND FLU RELIEF- acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled 
Major Pharmaceuticals

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.

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Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan Hydrobromide 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 pain
  • headache
  • minor aches & 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 for this product
  • 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 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see 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 sleep

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • 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 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 use more than directed
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • excitability may occur, especially in children
  • 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.

Overdose warning: Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.

Directions

  • take only as directed – see Overdose warning
  • do not exceed 4 doses per 24 hours
 adults and children 12 years and over swallow 2 softgels with water every 6 hours
 children 4 to under 12 years ask a doctor
 children under 4 years do not use
  • when using other Day time or Night time products, carefully read each label to insure correct dosing

Other information

  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat

Inactive ingredients

D&C Yellow #10, edible white printing ink, FD&C Blue #1, gelatin, glycerin, polyethylene glycol NF, povidone, propylene glycol, purified water, sorbitan, and sorbitol

Questions or comments?

 1-800-616-2471

Product Labeling

 MAJOR Night Time Multi- Symptom Cold/ Flu Relief

  • PAIN RELIEVER
  • FEVER REDUCER
  • COUGH SUPPRESSANT
  • ANTIHISTAMINE

ACETAMINOPHEN, Dextromethorphan HBr, Doxylamine Succinate

**Compare to the active ingredients in VICKS® NYQUIL®

**This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® NyQuil®

THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

 Major Night Time No PSE PE

Major Night Time Cold Flu Relief

MAJOR NIGHT TIME MULTI SYMPTOM  COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5764
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
SORBITAN 
SORBITOL 
Product Characteristics
ColorGREENScoreno score
ShapeCAPSULE (OBLONG) Size20mm
FlavorImprint Code P30;94A;35A
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-5764-1212 in 1 BLISTER PACK
2NDC:0904-5764-4416 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34103/01/2012
Labeler - Major Pharmaceuticals (191427277)

Revised: 08/2012
 
Major Pharmaceuticals