THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, phenylephrine hcl syrup

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Available from:
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Cough suppressant Nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
0067-8127-08

THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH- acetaminophen,

dextromethorphan hbr, phenylephrine hcl syrup

GlaxoSmithKline Consumer Healthcare Holdings (US) 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.

----------

Drug Facts

Active ingredients (in each 30 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

Warnings

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

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

temporarily relieves these symptoms due to a cold:

minor aches and pains

minor sore throat pain

headache

nasal and sinus congestion

cough due to minor throat and bronchial irritation

temporarily reduces fever

more than 4,000 mg of acetaminophen in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

skin reddening

blisters

rash

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

When using this product

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. Prompt medical

attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

in a child under 12 years of age

if you are allergic to acetaminophen

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.

liver disease

heart disease

high blood pressure

thyroid disease

diabetes

trouble urinating due to an enlarged prostate gland

cough that occurs with too much phlegm (mucus)

cough that lasts or is chronic such as occurs with smoking, asthma or emphysema

taking the blood thinning drug warfarin

do not exceed recommended dosage

nervousness, dizziness, or sleeplessness occurs

fever gets worse or lasts more than 3 days

redness or swelling is present

new symptoms occur

pain, cough or nasal congestion gets worse or lasts more than 7 days

cough comes back or occurs with rash or headache that lasts. These could be signs of a serious

condition.

Directions

Other information

Inactive ingredients

acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C blue no. 1, FD&C red no. 40,

flavors, glycerin, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

1-800-452-0051

Principal Display Panel

NDC 0067-8127-08

THERAFLU

ExpressMax

DAYTIME

SEVERE COLD & COUGH

BERRY FLAVOR

ACETAMINOPHEN

PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr

COUGH SUPPRESSANT

PHENYLEPHRINE HCl

NASAL DECONGESTANT

COUGH NASAL CONGESTION

do not use more than directed

measure the dose correctly using the enclosed dosing cup

take every 4 hours in dosing cup provided, while symptoms persist

do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Dose

adults and children 12 years of age and over

30 mL

children under 12 years of age

do not use

each 30 mL contains: potassium 35 mg, sodium 17 mg

store at controlled room temperature 20-25°C (68-77°F)

SORE THORAT PAIN FEVER

HEADACHE BODY ACHE

8.3 FL OZ (245.5mL)

Alcohol Free

* Maximum Strength per 4 hour dose.

DO NOT USE IF NECKBAND PRINTED WITH “SEALED FOR SAFETY” IS TORN OR

MISSING

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2018 GSK group of companies or its licensor.

13271

THERAFLU EXPRESSMAX DAYTIME SEVERE COLD AND COUGH

acetaminophen, dextromethorphan hbr, phenylephrine hcl syrup

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 0 6 7-8 127

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

6 50 mg

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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

ACETAMINOPHEN

6 50 mg

in 30 mL

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

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

20 mg

in 30 mL

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

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

10 mg

in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

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

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

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

GLYCERIN (UNII: PDC6 A3C0 OX)

MALTITO L (UNII: D6 5DG142WK)

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

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

SO DIUM CITRATE, UNSPECIFIED FO RM (UNII: 1Q73Q2JULR)

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

S core

S hap e

S iz e

Flavor

BERRY

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date Marketing End Date

1

NDC:0 0 6 7-8 127-

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

0 7/15/20 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 7/15/20 15

Labeler -

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 4/2019

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