Theraflu

Manufacturer: Haleon US Holdings LLC
Effective date: 2024-03-08
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-06-01 00:09:38

Label at a glance#

ProductTheraflu PowerPods Daytime Severe Cold

Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE

Label structure9 sections

Indications and uses

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

Dosage and administration

do not use more than directed take every 4 hours, while symptoms persist. Do not take more than 5 pods in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one pod children under 12 years of age do not use do not remove the foil seal as the pod will not work properly and could result in hot water burns place pod in compatible brewer use a minimum of 8 oz. of water when fin...

Storage and handling

each pod contains: potassium 10 mg, sodium 20 mg phenylketonurics: contains phenylalanine 14 mg per pod do not open pouch until time of use store at controlled room temperature 20 o -25 o C (68 o -77 o F). Protect product from heat and moisture.

Contacts and useful links#

PhoneLabel contact1-855-328-5259

Websitewww.stopmedicineabuse.org

www.StopMedicineAbuse.org

Label contents#

Full prescribing information#

Active ingredients (in each pod)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Phenylephrine HCl 10 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

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

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

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

OTC - DO NOT USE SECTION

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.

Ask doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

do not use more than directed
take every 4 hours, while symptoms persist. Do not take more than 5 pods in 24 hours unless directed by a doctor.

Age	Dose
adults and children 12 years of age and over	one pod
children under 12 years of age	do not use

do not remove the foil seal as the pod will not work properly and could result in hot water burns
place pod in compatible brewer
use a minimum of 8 oz. of water
when finished, the pod will be hot and may drip. Tilt the pod during removal to avoid dripping.
remove used pod and flush brewer after use with a minimum of 8 oz. of water
sip while hot. Consume entire drink within 10-15 minutes.

Other information

STORAGE AND HANDLING SECTION

each pod contains:potassium 10 mg, sodium 20 mg
phenylketonurics:contains phenylalanine 14 mg per pod
do not open pouch until time of use
store at controlled room temperature 20 ^o-25 ^oC (68 ^o-77 ^oF). Protect product from heat and moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-855-328-5259

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0067-6094-01

NEW

THERAFLU

POWERPODS

DAYTIME

SEVERE COLD

ACETAMINOPHEN – PAIN RELIEVER/FEVER REDUCER

DEXTROMETHORPHAN HBr – COUGH SUPPRESSANT

PHENYLEPHRINE HCl – NASAL DECONGESTANT

Nasal Congestion
Sore Throat Pain
Cough
Headache
Body Ache
Fever

BERRY INFUSED WITH MENTHOL & GREEN TEA FLAVORS

8 PODS

FOR USE ONLY WITH COMPATIBLE SINGLE SERVE BREWING MACHINES INCLUDING KEURIG AND MR. COFFEE*

*This product is not affiliated with Keurig Incorporated or Mr. Coffee.

READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE.

KEEP CARTON FOR REFERENCE. DO NOT DISCARD.

TAMPER EVIDENT POUCH. PRODUCT IS PACKAGED IN INDIVIDUAL SEALED POUCHES. DO NOT USE IF POUCH IS TORN OR BROKEN. DO NOT OPEN POUCH UNTIL TIME OF USE.

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

PRESS

Press the 8 oz. setting on your machine to brew.

SIP

Sip while hot. Consume entire drink within 10-15 minutes. Remove used pod and flush brewer after use

with a minimum of 8 oz. of water.

CAUTION: PRODUCT LIQUID AND POD WILL BE HOT.

RELIEF

Prepare to experience powerful cold & flu multi-symptom relief.

1-855-328-5259

Distributed by:

GSK Consumer Healthcare,Warren, NJ 07059

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

13019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1659967	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution	PSN	7
1659967	acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution	SCD	7
1659967	acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution	SY	7
1659967	APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEXTROMETHORPHAN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0067-6094-01	TherafluPowerPods Daytime Severe Cold	8 in 1 CARTON	POWDER, FOR SOLUTION	8	7
0067-6094-02	TherafluPowerPods Daytime Severe Cold	1 in 1 POUCH	POWDER, FOR SOLUTION	1	7
0067-6094-03	TherafluPowerPods Daytime Severe Cold	1 in 1 CARTON	POWDER, FOR SOLUTION	1	7
0067-6094-03	TherafluPowerPods Daytime Severe Cold	1 in 1 POUCH	POWDER, FOR SOLUTION	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0067-6094	THERAFLU POWERPODS DAYTIME SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC]	7	Current NDC, Legacy NDC, 4 package rows	20240310_e655c33c-c319-41d9-ae55-cf747242cd10.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0067-6094-01	EA - Each	0067-6094	4afd9b5c-37b7-4a89-9a52-6cff618c43b1	1	2018-08-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

Theraflu PowerPods Daytime Severe Cold
ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
ACESULFAME POTASSIUM
ANHYDROUS CITRIC ACID
ASPARTAME
FD&C BLUE NO. 1
FD&C RED NO. 40
MALTODEXTRIN
SILICON DIOXIDE
SODIUM CITRATE, UNSPECIFIED FORM
SUCROSE
TRIBASIC CALCIUM PHOSPHATE
ACETAMINOPHEN
DEXTROMETHORPHAN HYDROBROMIDE
DEXTROMETHORPHAN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0067-6094	0067-6094-02, 0067-6094-01, 0067-6094-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ACESULFAME POTASSIUM	23OV73Q5G9	IACT
ANHYDROUS CITRIC ACID	XF417D3PSL	IACT
ASPARTAME	Z0H242BBR1	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM CITRATE, UNSPECIFIED FORM	1Q73Q2JULR	IACT
SUCROSE	C151H8M554	IACT
TRIBASIC CALCIUM PHOSPHATE	91D9GV0Z28	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
DEXTROMETHORPHAN HYDROBROMIDE	9D2RTI9KYH	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Theraflu PowerPods Daytime Severe Cold	ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE	Haleon US Holdings LLC	e655c33c-c319-41d9-ae55-cf747242cd10	2024-03-08	Warnings	Exact identifier ndc (package): 0067-6094-01 ndc (package): 0067-6094-02 ndc (package): 0067-6094-03 ndc (product): 0067-6094 ndc11 (package): 00067609403 ndc11 (package): 00067609402 ndc11 (package): 00067609401 spl id: 132d9efd-0e0c-a2c7-e063-6294a90a1fe1 spl set id: e655c33c-c319-41d9-ae55-cf747242cd10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.