Severe Cold and Flu description, usages, side effects, indications, overdosage, supplying and lots more!

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Severe Cold and Flu

HyVee Inc

Hy-Vee, Inc. Severe Cold & Flu Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each 15 mL tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Severe Cold and Flu Uses

temporarily relieves common cold/flu symptoms:

  • •nasal congestion
  • •sinus congestion and pressure
  • •cough due to minor throat and bronchial irritation
  • •minor aches and pains
  • •headache
  • •fever
  • •sore throat
  • •reduces swelling of nasal passages
  • •temporarily restores freer breathing through the nose
  • •promotes nasal and/or sinus drainage
  • •helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (adult: 2,600 mg acetaminophen; child: 1,300 mg acetaminophen) in 24 hours. Severe liver damage may occur if

  • •adult takes more than 4,000 mg of acetaminophen in 24 hours
  • •child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • •taken with other drugs containing acetaminophen
  • •adult has 3 or more alcoholic drinks every day while using this product

Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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.
  • •if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

  • •liver disease
  • •diabetes
  • •thyroid disease
  • •high blood pressure
  • •heart disease
  • •trouble urinating due to an enlarged prostate gland
  • •cough that occurs with too much phlegm (mucus)
  • •persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin

When using this product

do not use more than directed

Stop use and ask a doctor if

  • •you get nervous, dizzy or sleepless
  • •pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • •redness or swelling is present
  • •fever gets worse or lasts more than 3 days
  • •new symptoms occur
  • •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

ask a health professional before use.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • •take only as directed – see Overdose warning
  • •use dose cup
  • •do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL (2 TBSP) every 4 hrs

children 6 to under 12 yrs

15 mL (1 TBSP) every 4 hrs

children 4 to under 6 yrs

ask a doctor

children under 4 yrs

do not use

  • •when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing

Other information

  • •each 15 mL tablespoon contains: sodium 6 mg
  • •store at 20-25°C (68-77°F)

Inactive ingredients

butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

Compare to the Active Ingredients of Vicks® DayQuil® Severe Cold & Flu

Max Strength

Severe Cold & Flu

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, EXPECTORANT, NASAL DECONGESTANT

Day Time

Non-Drowsy

Aches, Fever, Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

Chest Congestion – Guaifenesin

Nasal Congestion – Phenylephrine HCl

Alcohol Free/Antihistamine Free

Original Flavor

12 FL OZ (355 mL)

Severe Cold and Flu

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl SUSPENSION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42507-603
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 10 mg
Guaifenesin GUAIFENESIN 200 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYANISOLE
EDETATE DISODIUM
FD&C YELLOW NO. 6
GLYCERIN
MENTHOL
sodium phosphate, monobasic
POLYETHYLENE GLYCOLS
propylene glycol
water
saccharin sodium
SUCROSE
XANTHAN GUM

Product Characteristics

Color
ORANGE (clear)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42507-603-34 237 in 1 BOTTLE
2 NDC:42507-603-40 355 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-12


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