DAY RELIEF NIGHT RELIEF FREE- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl 
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 DayRelief and Night Relief Free Combo Pack Drug Facts

Active ingredient (in each 15 mL tablespoon) (for Nighttime)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredient (in each 15 mL tablespoon) (for Daytime)

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

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if:

adult takes more than 4 doses in 24 hours (Nighttime) or more than 6 doses in 24 hours (Daytime), which is the maximum daily amount
child takes more than 5 doses in 24 hours (Daytime)
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using these products

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

high blood pressure (Daytime only)
heart disease (Daytime only)
diabetes (Daytime only)
thyroid disease (Daytime only)
trouble urinating due to an enlarged prostate gland
liver disease
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
taking the blood thinning drug warfarin

When using these products

do not use more than directed

In addition, when using Nighttime:

avoid alcoholic drinks
marked drowsiness may occur
excitability may occur, especially in children
alcohol, sedatives and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

you get nervous, dizzy or sleepless (Daytime only)
new symptoms occur
fever gets worse or lasts more than 3 days
redness or swelling is present
pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

take as recommended - see Liver warning
take Nighttime OR Daytime
use dose cup

Nighttime Liquid

do not exceed 4 doses per 24 hours

adults and children 12 years and over

30 mL (2 TBSP) every 6 hours

children 4 to under 12 years

ask a doctor

children under 4 years

do not use

Daytime Liquid

do not exceed 5 doses (children) or 6 doses (adults) per 24 hours

adults and children 12 years and over

30 mL (2 TBSP) every 4 hours

children 6 to under 12 years

15 mL (1 TBSP) every 4 hours

children 4 to under 6 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

Other information

each TBSP of Nighttime contains: sodium 18 mg
each TBSP of Daytime 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, flavors, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Principal Display Panel

Buy 2 and Save!

(For Daytime)

Antihistamine-Free

Alcohol-Free

See New Warnings Information

DayRelief

Non-Drowsy Multi-Symptom Cold/Flu

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

Acetaminophen – Aches, Fever

Dextromethorphan HBr – Cough

Phenylephrine HCl – Nasal Congestion

Compare to Vicks® DayQuil® active ingredients

(For Nighttime)

Cherry Flavor

10% Alcohol

See New Warnings Information

NightRelief Free

Multi-Symptom Cold/Flu

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

DayRelief and NightRelief Free Combo Pack Carton

DayRelief and NightRelief Free Combo Pack Carton

DayRelief and NightRelief Free Combo Pack Carton

DAY RELIEF NIGHT RELIEF FREE 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55312-926
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-926-011 in 1 PACKAGE; Type 0: Not a Combination Product08/17/200712/14/2013
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 hydrobromide and doxylamine succinate liquid
Product Information
Item Code (Source)NDC:55312-041
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
WATER (UNII: 059QF0KO0R)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
Product Characteristics
ColorRED (Clear Dark) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-041-38296 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/15/200912/14/2013
Part 2 of 2
DAYRELIEF  NON DROWSY MULTI SYMPTOM COLD FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl solution
Product Information
Item Code (Source)NDC:55312-656
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorORANGE (clear) Score    
ShapeSize
FlavorMENTHOL (with fruit) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55312-656-38296 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34107/05/200612/14/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/17/200712/14/2013
Labeler - Western Family Foods Inc (192166072)

Revised: 10/2018
 
Western Family Foods Inc