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flu and sore throat

CVS Pharmacy

CVS Pharmacy, Inc. Flu and Sore Throat Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each packet)

Acetaminophen 650 mg

Pheniramine maleate 20 mg

Phenylephrine hydrochloride 10 mg

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

flu and sore throat 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.

flu and sore throat Other information

  • each packet contains: potassium 5 mg and sodium 46 mg
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

acesulfame potassium, 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, triacetin, tribasic calcium phosphate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients in Theraflu® Flu & Sore Throat

See New Warnings Information

Flu & Sore Throat

Soothing Warm Relief

Acetaminophen - Pain Reliever/Fever Reducer

Pheniramine Maleate - Antihistamine

Phenylephrine HCl - Nasal Decongestant

Nasal Congestion

Sore Throat

Headache

Body Ache

Fever

Runny Nose

Natural Apple Cinnamon Flavor

flu and sore throat
Flu and Sore Throat Carton

flu and sore throat

acetaminophen,pheniramine maleate, phenylephrine hydrochloride POWDER, FOR SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:59779-133
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
PHENIRAMINE MALEATE Pheniramine 20 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
ACESULFAME POTASSIUM
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
FD&C BLUE NO. 1
D&C YELLOW NO. 10
FD&C RED NO. 40
maltodextrin
SILICON DIOXIDE
SODIUM CHLORIDE
SODIUM CITRATE
LECITHIN, SOYBEAN
SUCROSE
triacetin
TRIBASIC CALCIUM PHOSPHATE

Product Characteristics

Color
YELLOW (light)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 15000 in 1 PACKET
2 NDC:59779-133-91 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2010-07-07


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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