DAY TIME COLD/FLU RELIEF

Main information

  • Trade name:
  • DAY TIME COLD/FLU RELIEF - acetaminophen, dextromethorphan, phenylephrine liquid
  • Composition:
  • ACETAMINOPHEN 325 mg in 15 mL
  • Administration route:
  • ORAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DAY TIME COLD/FLU RELIEF - acetaminophen, dextromethorphan, phenylephrine liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Pain reliever/fever reducer Cough suppressant Nasal decongestant temporarily relieves common cold/flu symptoms: - nasal decongestion - cough due to minor throat and bronchial irritation - sore throat - headache - minor aches and pains - fever

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 67510-0544-0, 67510-0544-2, 67510-0544-4, 67510-0544-6
  • Last update:
  • 19-06-2019

Summary of Product characteristics: dosage, interactions, side effects

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

Kareway Product, 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.

----------

Drug Facts

Active ingredients(in each 15 ml tablespoon)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Us es

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

Enter section text here

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.

Enter section text here

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

Daytime Cold/Flu Relief

DAY TIME COLD/FLU RELIEF

acetaminophen, dextromethorphan, phenylephrine liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 7510 -0 544

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

in 15 mL

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

in 15 mL

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

in 15 mL

Inactive Ingredients

Ingredient Name

Stre ng th

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

Kareway Product, Inc.

GLYCERIN (UNII: PDC6 A3C0 OX)

PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

WATER (UNII: 0 59 QF0 KO0 R)

SO DIUM CITRATE (UNII: 1Q73Q2JULR)

SUCRO SE (UNII: C151H8 M554)

SUCRALO SE (UNII: 9 6 K6 UQ3ZD4)

SACCHARIN SO DIUM DIHYDRATE (UNII: SB8 ZUX40 TY)

XANTHAN GUM (UNII: TTV12P4NEE)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 7510 -0 544-4

120 mL in 1 BOTTLE

2

NDC:6 7510 -0 544-6

177 mL in 1 BOTTLE

3

NDC:6 7510 -0 544-0

29 5 mL in 1 BOTTLE

4

NDC:6 7510 -0 544-2

354 mL in 1 BOTTLE

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

0 9 /0 6 /20 11

Labeler -

Kareway Product, Inc. (121840057)

Revised: 7/2012