DAYTIME SEVERE

Main information

  • Trade name:
  • DAYTIME SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
  • 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 SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant temporarily relieves common cold/flu symptoms: taking the blood thinning drug warfarin

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph final
  • Authorization number:
  • 37012-603-40
  • Last update:
  • 22-06-2019

Summary of Product characteristics: dosage, interactions, side effects

DAYTIME SEVERE- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine

hcl solution

Shopko Stores Operating Co., LLC

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.

----------

Shopko Daytime Severe Drug Facts

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpos e

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Us es

temporarily relieves common cold/flu symptoms:

Warnings

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

sore throat

nasal congestion

sinus congestion and pressure

cough due to minor throat and bronchial irritation

minor aches and pains

fever

headache

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of

bothersome mucus and make coughs more productive

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

child takes more than 5 doses in 24 hours

taken with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

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

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

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

skin reddening

blisters

rash

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.

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

liver disease

heart disease

diabetes

thyroid disease

high blood pressure

trouble urinating due to an enlarged prostate gland

cough that occurs with too much phlegm (mucus)

persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or

emphysema

pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)

you get nervous, dizzy or sleepless

fever gets worse or lasts more than 3 days

redness or swelling is present

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: 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

adults & children 12 yrs & over

30 mL every 4 hrs

children 6 to under 12 yrs

15 mL 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 #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

Package/Label Principal Display Panel

Compare to Dayquil® Severe active ingredients

SEE NEW WARNINGS

DAYTIME SEVERE

COLD & FLU RELIEF

PAIN RELIEVER/FEVER REDUCER

ACETAMINOPHEN

COUGH SUPPRESSANT

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 Overdose warning

only use the dose cup provided

do not exceed 4 doses per 24 hrs

each 15 mL contains: sodium 6 mg

store at 20-25 C (68-77 F). Do not refrigerate.

DEXTROMETHORPHAN HBr

EXPECTORANT

GUAIFENESIN

NASAL DECONGESTANT

PHENYLEPHRINE HCl

ORIGINAL FLAVOR

12 FL OZ (354 mL)

DAYTIME SEVERE

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:370 12-6 0 3

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

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

in 15 mL

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

in 15 mL

Shopko Stores Operating Co., LLC

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 LS (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

FRUIT, MENTHOL

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:370 12-6 0 3-40

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

0 9 /0 2/20 15

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 2/20 15

Labeler -

Shopko Stores Operating Co., LLC (023252638)

Revised: 6/2018