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Name:Night Reliefmulti Symptom Cold And Flu
Manufacturer:Western Family Foods Inc
Category:Over-the-counter (OTC) Marketed Drugs


Western Family NightRelief Multi-Symptom Cold/Flu Drug Facts

NIGHT RELIEF MULTI SYMPTOM COLD AND FLU - acetaminophen, dextromethorphan hydrobromide and doxylamine succinate capsule, liquid filled 
Western Family Foods Inc

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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Western Family NightRelief Multi-Symptom Cold/Flu Drug Facts

Active ingredient (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 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
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 softgels in 24 hours, which is the maximum daily amount
  • 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, 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.
  • to make a child sleepy

Ask a doctor before use if you have

  • liver disease
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis
  • persistent or chronic cough as occurs with smoking, asthma or emphysema
  • trouble urinating due to an 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
  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • 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.

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • take only as recommended – see Liver warning
  • do not exceed 4 doses per 24 hours
adults and children 12 years and over 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 Daytime or Nighttime products, carefully read each label to insure correct dosing

Inactive ingredients

D&C yellow no. 10, edible ink, FD&C blue no. 1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Principal Display Panel

See New Warnings Information

Liquid Caps

NightRelief

Multi-Symptom Cold/Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

Acetaminophen – Aches, Fever

Dextromethorphan HBr – Cough

Doxylamine Succinate – Sneezing, Runny Nose

Alcohol-Free

Compare to Vicks® NyQuil® active ingredients

NightRelief Carton Image 1

NightRelief Carton Image 1

NightRelief Carton Image 2

NightRelief Carton Image 2


NIGHT RELIEF  MULTI SYMPTOM COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsule, liquid filled
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55312-977
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 15 mg
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 6.25 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10  
FD&C BLUE NO. 1  
GELATIN  
GLYCERIN  
MANNITOL  
POLYETHYLENE GLYCOL  
POVIDONE  
PROPYLENE GLYCOL  
WATER  
SORBITAN  
SORBITOL  
Product Characteristics
Color GREEN Score no score
Shape CAPSULE (OBLONG) Size 20mm
Flavor Imprint Code L977
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55312-977-53 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK
1 12 CAPSULE, LIQUID FILLED ( CAPSULE) in 1 BLISTER PACK This package is contained within the CARTON (55312-977-53)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/09/2007

Labeler - Western Family Foods Inc (192166072)

Revised: 07/2009 Western Family Foods Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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