Search by Drug Name or NDC

NDC 00067-6089-01 Theraflu 20; 400 mg/1; mg/1 Details

Theraflu 20; 400 mg/1; mg/1

Theraflu is a ORAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.

MedlinePlus Drug Summary

Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.

Related Packages: 00067-6089-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan

Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.

Related Packages: 00067-6089-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Guaifenesin

Product Information

NDC	00067-6089
Product ID	0067-6089_b7b2ee07-9848-415d-a071-f0b6458f83ca
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Theraflu
Proprietary Name Suffix	Cough Relief
Non-Proprietary Name	Dextromethorphan HBr, Guaifenesin
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER, FOR SOLUTION
Route	ORAL
Active Ingredient Strength	20; 400
Active Ingredient Units	mg/1; mg/1
Substance Name	DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Labeler Name	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Pharmaceutical Class	Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00067-6089-01 (00067608901)

Pricing Information	N/A
NDC Package Code	0067-6089-01
Billing NDC	00067608901
Package	6 PACKET in 1 CARTON (0067-6089-01) / 1 POWDER, FOR SOLUTION in 1 PACKET (0067-6089-03)
Marketing Start Date	2019-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 11053b13-0f15-49e9-a034-5c65eef48d11 Details

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
: Trademarks are owned or licensed to the GSK group of companies.
: 62000000027600

6200000002760_Theraflu Cough Relief_6 packets.JPG

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	07/01/2019

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

Revised: 12/2020

Document Id: b7b2ee07-9848-415d-a071-f0b6458f83ca

Set id: 11053b13-0f15-49e9-a034-5c65eef48d11

Version: 3

Effective Time: 20201215