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NightRelief DayRelief

Dosage form: kit
Ingredients: ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL, DOXYLAMINE SUCCINATE 6.25mg in 15mL; ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 15mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 15mL
Labeler: Western Family Foods Inc
NDC Code: 55312-733

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.

Western Family Night Relief Day Relief Drug Facts

Active ingredients for Nighttime (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredients for Daytime (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

nasal congestion (Daytime only)
cough due to minor throat and bronchial irritation
sore throat
headache
minor aches and pains
fever
runny nose and sneezing (Nighttime only)

Warnings

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

adult takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
child takes more than 4 doses in 24 hours (Daytime only)
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is 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 these products.
to make a child sleepy (Nighttime only)
if you have ever had an allergic reaction to these products or any of their ingredients

Ask a doctor before use if you have
liver disease
heart disease (Daytime only)
thyroid disease (Daytime only)
diabetes (Daytime only)
high blood pressure (Daytime only)
trouble urinating due to an enlarged prostate gland
cough that occurs with too much phlegm (mucus)
persistent or chronic cough as occurs with smoking, asthma, or emphysema
a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
glaucoma (Nighttime only)
a sodium-restricted diet (Nighttime only)

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers (Nighttime only)
taking the blood thinning drug warfarin

When using these products
do not use more than directed

In addition, when using Nighttime:

excitability may occur, especially in children
marked drowsiness may occur
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
you get nervous, dizzy or sleepless (Daytime only)
pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults) (Daytime only)
pain or cough gets worse or lasts more than 7 days (Nighttime only)
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 directed - see Liver warning
take Nighttime or Daytime
use dose cup
do not exceed 4 doses per 24 hrs

Nighttime

adults & children 12 yrs & over

30 ml (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

 
Daytime

adults & children 12 yrs & over

30 ml (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 ml (1 TBSP) every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

Other information
(Nighttime) each tablespoon contains: sodium 19 mg
(Daytime) each tablespoon contains: sodium 7 mg
store at 20°-25°C (68°-77°F)

Inactive ingredients

Nighttime alcohol, anhydrous citric acid, FD&C blue no. 1, FD&C red no. 40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Principal Display Panel for Nighttime

CHERRY FLAVOR

10% ALCOHOL

See New Warnings and Dosing Information

Gluten Free

NightRelief Free

MULTI-SYMPTOM COLD/FLU

BUY 2 and SAVE!

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, ANTIHISTAMINE

ACETAMINOPHEN – aches, fever

DEXTROMETHORPHAN HBr – cough

DOXYLAMINE SUCCINATE – sneezing, runny nose

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

COMPARE TO VICKS® NYQUIL® active ingredients

10 FL OZ (296 ml)

Package/Label Principal Display Panel - Daytime

ANTIHISTAMINE FREE

ALCOHOL FREE

See New Warnings and Dosing Information

Gluten Free

DayRelief

NON-DROWSY MULTI-SYMPTOM COLD/FLU

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, NASAL DECONGESTANT

BUY 2 and SAVE!

ACETAMINOPHEN – aches, fever

DEXTROMETHORPHAN HBr – cough

PHENYLEPHRINE HCl – nasal congestion

COMPARE TO VICKS® DAYQUIL® active ingredients

10 FL OZ (296 ml)

NIGHTRELIEF DAYRELIEF 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-733
Packaging
#Item CodePackage Description
1NDC:55312-733-011 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 296 mL
Part 21 BOTTLE 296 mL
Part 1 of 2
NIGHT RELIEF FREE 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL 
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SODIUM CITRATE 
Product Characteristics
ColorRED (Clear, Dark Red) Score    
ShapeSize
FlavorCHERRY (Menthol Aroma) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/29/2011
Part 2 of 2
DAYRELIEF  NON DROWSY MULTI SYMPTOM COLD FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYANISOLE 
EDETATE DISODIUM 
FD&C YELLOW NO. 6 
GLYCERIN 
MENTHOL 
SODIUM PHOSPHATE, MONOBASIC 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
SUCROSE 
XANTHAN GUM 
Product Characteristics
ColorORANGE (clear) Score    
ShapeSize
FlavorMENTHOL (with fruit) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1296 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/2006
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/02/2012
Labeler - Western Family Foods Inc (192166072)

Revised: 03/2014
 
Western Family Foods Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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