THERAFLU COUGH RELIEF- dextromethorphan hbr, guaifenesin powder, for solution

Theraflu by

Drug Labeling and Warnings

Theraflu by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each packet)

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg

Purposes

Cough suppressant

Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use

• in a child under 12 years of age
• 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

• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
• a sodium-restricted diet

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back or occurs with fever, 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.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

• do not use more than directed
• take every 4 hours. Do not take more than 6 packets in 24 hours.

• Age:

  Dose

• adults and children 12 years of age and over:

  one packet

• children under 12 years of age:

  do not use

• dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
• if using microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.

Other information

• each packet contains: potassium 10 mg, sodium 39 mg
• phenylketonurics: contains phenylalanine 24 mg per packet
• store at controlled room temperature 20-25°C (68-77°F)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FDC blue no. 1, FDC red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, sucrose, tribasic calcium phosphate

Questions or comments?

call 1-855-328-5259

Principal Display Panel

NDC: 0067-6089-01

NEW

THERAFLU

COUGH RELIEF

DEXTROMETHORPHAN HBr

•   COUGH SUPPRESSANT

GUAIFENESIN

•   EXPECTORANT

• 1. Controls Cough
• 2. Loosens Chest Congestion
•   HONEY LEMON INFUSED WITH CHAMOMILE & WHITE TEA FLAVORS
•   6 PACKETS
•   PARENTS:
•   Learn about teen medicine abuse
•   www.StopMedicineAbuse.org
•   TAMPER EVIDENT INNER UNIT
•   DO NOT USE IF SEALED THERAFLU PACKET IS TORN OR BROKEN
•   READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE. KEEP CARTON FOR REFERENCE. DO NOT DISCARD.
•   1-855-328-5259
•   Distributed by:
•   GSK Consumer Healthcare, Warren, NJ 07059
•   © 2018 GSK group of companies or its licensor.
•   Trademarks are owned or licensed to the GSK group of companies.
•   62000000027600

INGREDIENTS AND APPEARANCE

THERAFLU  COUGH RELIEF
dextromethorphan hbr, guaifenesin powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0067-6089
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
SUCROSE (UNII: C151H8M554)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0067-6089-01	6 in 1 CARTON	07/01/2019
1	NDC: 0067-6089-03	1 in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2019

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)