DAYTIME NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

DayTime NightTime Cold and Flu by

Drug Labeling and Warnings

DayTime NightTime Cold and Flu by is a Otc medication manufactured, distributed, or labeled by Safeway, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients for Day Time (in each 15 mL, 1 tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients for Night Time (in each 30 mL, 2 tablespoons)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Purposes for Day Time

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Night Time

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

• temporarily relieves common cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • fever
  • cough due to minor throat and bronchial irritation
  • nasal congestion (Day Time only)
  • coughs (Night Time only)

Warnings

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

• more than 6 doses (12 tablespoons or 180 mL) in 24 hours for adults (Day Time only)
• more than 5 doses (5 tablespoons or 75 mL) in 24 hours for children 6-12 years old (Day Time only)
• 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

• to make a child sleep (Night Time only)
• 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.
• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask a doctor before use if you have

• liver disease
• a sodium-restricted diet
• trouble urinating due to an enlarged prostate gland
• cough accompanied by excessive phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• diabetes (Day Time only)
• heart disease (Day Time only)
• thyroid disease (Day Time only)
• high blood pressure (Day Time only)
• glaucoma (Night Time only)
• breathing problem (Night Time only)
• chronic bronchitis (Night Time only)

Ask a doctor or pharmacist before use if you are taking

• the blood thinning drug warfarin

• sedatives or tranquilizers (Night Time only)

When using these product,

• do not use more than directed (see overdose warning)
• avoid alcoholic drinks
• excitability may occur, especially in children (Night Time only)
• be careful when driving a motor vehicle or operating machinery (Night Time only)
• alcohol, sedatives, and tranquilizers may increase drowsiness (Night Time only)
• marked drowsiness may occur (Night Time only)

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur (Daytime only)
• redness or swelling is present
• fever gets worse or lasts more than 3 days
• pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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 the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222)  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 only as recommended (see overdose warning)
• measure only with dosing cup provided
• keep dosing cup with product
• tbsp=tablespoon. mL= milliliter
• When using day Time and Night Time products, carefully read each label to ensure correct dosing.

Daytime

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

• age: dose
• adults and children 12 years and over: 2 tbsp (30 mL) every 4 hours
• children 6 to 11 years: 1 tbsp (15 mL) every 4 hours
• children 4 to 5 years: do not use unless directed by a doctor
• children under 4 years: do not use

Nighttime

• do not exceed 4 doses per 24 hours

• age: dose
• adults and children 12 years and over: 2 tbsp (30 mL) every 6 hours
• children 4 to 11 years: do not use unless directed by a doctor
• children under 4 years: do not use

Other information

• each 15 mL contains: sodium 71 mg (Day Time only)
• each 30 mL contains: potassium 10 mg, sodium 38 mg (Night Time only) 
• store at 20°-25°C (68°-77°F). Do not refrigerate.

Inactive ingredients

Inactive ingredients for Day Time 

citric acid, FD&C yellow #6, glycerin, natural & artifical flavor, polyethylene glycol 300, propylene glycol, purified water, saccharin sodium, sodium citrate, sucrose

Inactive ingredients for Night Time 

acesulfame potassium, alcohol, Fd&C blue #1, FD& red #40, citric acid, high fructose corn syrup, natural & artificial flavor, polyethylene glycol 300, propylene glycol, purified water, saccharin sodium, sodium citrate

Principal Display Panel

Non-Drowsy

Daytime

Cold & Flu Relief

Acetaminophen 325 mg- Pain reliever/fever reducer

Dextromethorphan HBr 10 mg- Cough Suppressant

Phenylephrine HCl 5 mg- nasal decongestant

Original Flavor

Compare to Vicks®DayQuil® active ingredients

• Alcohol free
• Antihistamine free

Nighttime

Cold & Flu Relief

Acetaminophen 650 mg- pain reliever/ fever reducer

Dextromethorphan HBr 30 mg-Cough suppressant

Doxylamine Succinate 12.5 mg- antihistamine

Cherry flavor

Compare to Vicks®NyQuil® active ingredients*

• relieves major cold and flu like symptoms
• all night cold relief

10% alcohol

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFTEY SEAL IS BROKEN OR MISSING.

DISTRIBUTED BY SAFEWAY INC.

P.O BOX 99, PLEASANTON, CA 94566-0009

1-888-SAFEWAY

www.safeway.com

Product Label

Safeway daytime nighttime cold and flu relief

INGREDIENTS AND APPEARANCE

DAYTIME NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-419

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-419-24	1 in 1 KIT; Type 0: Not a Combination Product	06/30/2014	12/31/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	355 mL
Part 2	1 BOTTLE	355 mL

Part 1 of 2

DAYTIME COLD AND FLU RELIEF  NON-DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341

Part 2 of 2

NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hbr, doxylamine succinate liquid

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ALCOHOL (UNII: 3K9958V90M)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/30/2014	12/31/2020

Labeler - Safeway, Inc. (009137209)