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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Theraflu Daytime Severe Cold and Cough

Drug Facts

Active ingredients (in each packet)Purposes
Acetaminophen 650 mgPain reliever/fever reducer
Dextromethorphan HBr 20 mgCough suppressant
Phenylephrine HCl 10 mgNasal decongestant

Uses

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

Other information

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

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

Principal Display Panel - 20 Packet Carton
THERAFLU DAYTIME SEVERE COLD AND COUGH 
acetaminophen, dextromethorphan, phenylephrine powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-896(NDC:0067-7917)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D) acetaminophen650 mg
dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (dextromethorphan - UNII:7355X3ROTS) dextromethorphan hydrobromide20 mg
phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride10 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-896-031 in 1 BLISTER PACK04/30/2018
11 in 1 PACKET; Type 0: Not a Combination Product
2NDC:52904-896-2020 in 1 CARTON04/30/2018
21 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34104/30/2018
Labeler - Select Corporation (053805599)

Revised: 4/2022
Document Id: 1445cde1-5870-42b8-9451-b35c7d18447d
Set id: 60acfcf4-5b55-40ef-b432-faeed8457881
Version: 1
Effective Time: 20220429
 
Select Corporation