equaline flu and sore throat

Dosage form: powder, for suspension
Ingredients: ACETAMINOPHEN 650mg in 15000mg, PHENIRAMINE MALEATE 20mg in 15000mg, PHENYLEPHRINE HYDROCHLORIDE 10mg in 15000mg
Labeler: Supervalu Inc
NDC Code: 41163-133

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.

SuperValu Inc. Flu & Sore Throat Drug Facts

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 over

dissolve 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 age

consult a doctor

children under 4 years of age

do 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

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 
MEDIUM-CHAIN TRIGLYCERIDES 
Product Characteristics
ColorYELLOW (light) Score    
ShapeSize
FlavorAPPLEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-133-916 POUCH in 1 CARTON
115000 mg in 1 POUCH
2NDC:41163-133-518 POUCH in 1 CARTON
215000 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: 04/2013
 
Supervalu Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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