THERAFLU DAYTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan, phenylephrine powder, for solution

Theraflu Daytime Severe Cold and Cough by

Drug Labeling and Warnings

Theraflu Daytime Severe Cold and Cough by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each packet)	Purposes
Acetaminophen 650 mg	Pain reliever/fever reducer
Dextromethorphan HBr 20 mg	Cough suppressant
Phenylephrine HCl 10 mg	Nasal decongestant

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

Warnings

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

• 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 a doctor before use if you have

• 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

• taking the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage

Stop use and ask a doctor if

• 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, 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.

Directions

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

  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 a 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 20 mg
• phenylketonurics: contains phenylalanine 14 mg per packet
• store at controlled room temperature 20°-25°C (68°-77°F). Protect product from heat and moisture.

Inactive ingredients

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?

call 1-855-328-5259

SPL UNCLASSIFIED SECTION

Packaged and distributed by Select Corporation with the permission of GSK Consumer Healthcare
Warren, NJ 07059

PRINCIPAL DISPLAY PANEL - 20 Packet Carton

gsk

THERAFLU

SEVERE
COLD & COUGH

DAYTIME

Acetaminophen
Pain Reliever/Fever Reducer

Dextromethorphan HBr
Cough Suppressant

Phenylephrine HCl
Nasal Decongestant

• ▶ Cough
• ▶ Nasal Congestion
• ▶ Sore Throat Pain
• ▶ Headache
• ▶ Body Ache
• ▶ Fever

BERRY INFUSED
WITH MENTHOL &
GREEN TEA FLAVORS

20 PACKETS

INGREDIENTS AND APPEARANCE

THERAFLU DAYTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan, phenylephrine powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-896(NDC:0067-7917)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)	acetaminophen	650 mg
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS)	dextromethorphan hydrobromide	20 mg
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV)	phenylephrine hydrochloride	10 mg

Inactive Ingredients
Ingredient Name	Strength
acesulfame potassium (UNII: 23OV73Q5G9)
anhydrous citric acid (UNII: XF417D3PSL)
aspartame (UNII: Z0H242BBR1)
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: 52904-896-03	1 in 1 BLISTER PACK	04/30/2018
1		1 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 52904-896-20	20 in 1 CARTON	04/30/2018
2		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	04/30/2018

Labeler - Select Corporation (053805599)