DAYTIME COLD AND FLU RELIEF NON DROWSY

Main information

  • Trade name:
  • DAYTIME COLD AND FLU RELIEF NON DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine hcl 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:
  • DAYTIME COLD AND FLU RELIEF NON DROWSY- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Pain reliever/fever reducer Cough suppressant Nasal decongestant temporarily relieves common cold/flu symptoms:

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 0363-0656-30, 0363-0656-34, 0363-0656-38, 0363-0656-40
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

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

phenylephrine hcl liquid

Walgreen Company

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.

----------

Walgreen Co. Cold & Flu Relief Drug Facts

Active ingredients (in each 15 ml tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4

doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. Severe liver

damage may occur if

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

nasal congestion

cough due to minor throat and bronchial irritation

sore throat

headache

minor aches and pains

fever

adult takes more than 4,000 mg of acetaminophen in 24 hours

child takes more than 5 doses in 24 hours, which is the maximum daily amount

taken with other drugs containing acetaminophen

adult has 3 or more alcoholic drinks every day while using this product

with any other drug containing acetaminophen (prescription or nonprescription). If you are not

Ask a doctor before use if you have

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

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

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.

if you have ever had an allergic reaction to this product or any of its ingredients

liver disease

heart disease

thyroid disease

diabetes

high blood pressure

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

you get nervous, dizzy or sleepless

pain, nasal congestion or cough gets worse or lasts 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.

take only as directed – see Liver warning

use dose cup

do not exceed 4 doses per 24 hrs

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 6 yrs

ask a doctor

children under 4 yrs

do not use

Other information

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

NON-DROWSY - DAYTIME

Cold & Flu Relief

Acetaminophen / Aches / Fever

Dextromethorphan HBr / Cough

Phenylephrine HCl / Nasal Congestion

Pain reliever, fever reducer, cough suppressant & nasal decongestant

Alcohol free

Antihistamine free

Compare to Vicks® DayQuil® active ingredients

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

dosing

each tablespoon contains: sodium 7 mg

store at 20°-25°C (68°-77°F)

DAYTIME COLD AND FLU RELIEF NON DROWSY

acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 36 3-0 6 56

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Walgreen Company

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

BUTYLATED HYDRO XYANISO LE (UNII: REK49 6 0 K2U)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

GLYCERIN (UNII: PDC6 A3C0 OX)

MENTHO L (UNII: L7T10 EIP3A)

SO DIUM PHO SPHATE, MO NO BASIC (UNII: 39 8 0 JIH2SW)

PO LYETHYLENE GLYCO L (UNII: 3WJQ0 SDW1A)

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

WATER (UNII: 0 59 QF0 KO0 R)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SUCRO SE (UNII: C151H8 M554)

XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics

Color

ORANGE (clear)

S core

S hap e

S iz e

Flavor

MENTHOL (with fruit)

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 36 3-0 6 56 -30

177 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/28 /20 0 6

2

NDC:0 36 3-0 6 56 -38

29 6 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 7/0 7/20 0 6

3

NDC:0 36 3-0 6 56 -40

355 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 8 /15/20 0 7

4

NDC:0 36 3-0 6 56 -34

237 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 9 /0 4/20 12

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 7/0 7/20 0 6

Labeler -

Walgreen Company (008965063)

Revised: 12/2018