Indications and 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
Theraflu
- Manufacturer
- GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Effective date
- 2020-12-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:01:49
Label at a glance#
ProductTheraflu Cough Relief
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
Label structure9 sections
Dosage and administration
• 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 ...
Contacts and useful links#
Websitewww.stopmedicineabuse.org
www.StopMedicineAbuse.org
www.StopMedicineAbuse.orgLabel contents#
Full prescribing information#
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
- Controls Cough
- 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
Products#
Every source-derived product name is available through these pages.
- Theraflu Cough Relief
- Dextromethorphan HBr, Guaifenesin
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- ACESULFAME POTASSIUM
- ANHYDROUS CITRIC ACID
- ASPARTAME
- D&C YELLOW NO. 10
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- MALTODEXTRIN
- SILICON DIOXIDE
- SODIUM CITRATE, UNSPECIFIED FORM
- SUCROSE
- TRIBASIC CALCIUM PHOSPHATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0067-6089 | 0067-6089-03, 0067-6089-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| e5f9bf96-b312-4dfe-a9d7-ac53bd72fad7 | 11053b13-0f15-49e9-a034-5c65eef48d11 | 2022-12-31 | Warnings | 11053b13-0f15-49e9-a034-5c65eef48d11 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.