DAY TIME COLD/FLU RELIEF- acetaminophen, dextromethorphan, phenylephrine liquid

Day Time Cold/Flu Relief by

Drug Labeling and Warnings

Day Time Cold/Flu Relief by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients(in each 15 ml tablespoon)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

temporarily relieves common cold/flu symptoms:

• nasal decongestion
  
• cough due to minor throat and bronchial irritation
• sore throat
• headache
• minor aches and pains
• fever

Warnings

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Liver warning

This product contains acetaminophen.  Severe liver damage may occur if adult/child takes

• more than 4 doses in 24 hrs, which is the maximum daily amount for this product
• 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, 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.

Ask a doctor before use if you have

• liver disease
• heart disease
• thyroid disease
• diabetes
• high blood pressure
  
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phegm(mucus)
• Persistent or chronic cough as occurs with smoking, asthma, emphysema
• a sodium-restricted diet
  

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• symptoms get worse or last more than 5 days (children) or 7 days (adults)
  
• 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.

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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 children even if you do not notice any signs or symptoms.

Directions

• take only as directed-see Overdose warning
• use dose cup or tablespoon (TBSP)
  
• do not exceed 4 doses per 24 hours
  • adults and children 12 yrs and over: 30 ml (2 TBSP) every 6 hours
  • children 6 to under 12 yrs: 15 ml (1 TBSP) every 4 hours
  • children 4 to under 6 yrs: ask a doctor
  • children under 4 yrs: do not use

Other information

• each tablespoon contains: sodium 50mg
  
• store at room temperature
  

Inactive ingredients

citric acid, FDC red no.40, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium,
sodium citrate, sucralose, sucrose, xanthan gum

PRINCIPAL DISPLAY PANEL

Daytime Cold/Flu Relief

INGREDIENTS AND APPEARANCE

DAY TIME COLD/FLU RELIEF 
acetaminophen, dextromethorphan, phenylephrine liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0544
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67510-0544-4	120 mL in 1 BOTTLE
2	NDC: 67510-0544-6	177 mL in 1 BOTTLE
3	NDC: 67510-0544-0	295 mL in 1 BOTTLE
4	NDC: 67510-0544-2	354 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/06/2011

Labeler - Kareway Product, Inc. (121840057)