EQUALINE FLU AND SORE THROAT- acetaminophen, pheniramine maleate and phenylephrine hydrochloride powder, for suspension 
Supervalu Inc

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.

----------

Active ingredient (in each packet)

Acetaminophen 650 mg

Pheniramine maleate 20 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

  • temporarily relieves these symptoms due to a cold:
  • minor aches and pains
  • headache
  • minor sore throat
  • nasal congestion
  • temporarily reduces fever
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy nose and throat
  • itchy, watery eyes

Warnings

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

  • more than 6 doses in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

  • 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.
  • to make a child sleepy

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema, asthma or chronic bronchitis
  • trouble urinating due to an enlarged prostate gland
  • a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

  • do not use more than directed
  • avoid alcoholic drinks
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • pain or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting

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. Quick 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 – see Liver warning
  • take every 4 hours; do not exceed 6 packets in 24 hours or as directed by a doctor
adults and children 12 years of age and overdissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
children 4 to under 12 years of ageconsult a doctor
children under 4 years of agedo not use
  • 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 5 mg and sodium 46 mg
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, anhydrous citric acid, colloidal silicon dioxide, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, medium chain triglycerides, mono- and diglycerides, pregelatinized starch, silicon dioxide, sodium chloride, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate

Questions or comments?

1-877-932-7948

Principal Display Panel

compare to Theraflu® Flu & Sore Throat active ingredients

flu & sore throat

pain reliever/fever reducer (acetaminophen)

antihistamine (pheniramine maleate)

nasal decongestant (phenylephrine HCl)

sore throat

body ache

headache

nasal congestion

fever

runny nose

natural apple cinnamon flavor

see new warnings information

Flu and Sore Throat Carton Image 1

Flu & Sore Throat Carton Image 1

Flu and Sore Throat Carton Image 2

Flu & Sore Throat Carton Image 2

EQUALINE FLU AND SORE THROAT 
acetaminophen,pheniramine maleate, phenylephrine hydrochloride powder, for suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-133
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN650 mg  in 15000 mg
PHENIRAMINE MALEATE (PHENIRAMINE) PHENIRAMINE MALEATE20 mg  in 15000 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE10 mg  in 15000 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM 
ANHYDROUS CITRIC ACID 
D&C YELLOW NO. 10 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
MALTODEXTRIN 
SILICON DIOXIDE 
SODIUM CHLORIDE 
SODIUM CITRATE 
LECITHIN, SOYBEAN 
SUCROSE 
TRIBASIC CALCIUM PHOSPHATE 
SILICON DIOXIDE 
Product Characteristics
ColorYELLOW (light) Score    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-133-916 in 1 CARTON
115000 mg in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/03/2011
Labeler - Supervalu Inc (006961411)

Revised: 12/2011
Document Id: 4276a199-0022-4520-9eba-c6681c4a5350
Set id: 4276a199-0022-4520-9eba-c6681c4a5350
Version: 1
Effective Time: 20111227
 
Supervalu Inc