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

Cold and Flu

HyVee Inc

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Hy-Vee, Inc. Cold & Flu Drug Facts

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg

Active ingredients (in each 15 mL tablespoon) - Daytime

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose - Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose - Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses - Nighttime

temporarily relieves common cold/flu symptoms:

  • •headache
  • •cough due to minor throat and bronchial irritation
  • •sore throat
  • •minor aches and pains
  • •runny nose and sneezing
  • •fever

Uses - Daytime

temporarily relieves common cold/flu symptoms:

  • •cough due to minor throat and bronchial irritation
  • •sore throat
  • •headache
  • •minor aches and pains
  • •fever
  • •nasal congestion

Warnings - Nighttime

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 4 doses (2,600 mg acetaminophen) in 24 hours. 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

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.

Warnings - Daytime

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 - Nighttime

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

Do not use - Daytime

  • •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 - Nighttime

  • •liver disease
  • •trouble urinating due to an enlarged prostate gland
  • •cough that occurs with too much phlegm (mucus)
  • •persistent or chronic cough as occurs with smoking, asthma, or emphysema
  • •a breathing problem such as emphysema or chronic bronchitis
  • •glaucoma
  • •a sodium-restricted diet

Ask a doctor before use if you have - Daytime

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

Ask a doctor or pharmacist before use if you are - Nighttime

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

Ask a doctor or pharmacist before use if you are - Daytime

taking the blood thinning drug warfarin

When using this product - Nighttime

  • •excitability may occur, especially in children
  • •marked drowsiness may occur
  • •avoid alcoholic drinks
  • •be careful when driving a motor vehicle or operating machinery
  • •alcohol, sedatives, and tranquilizers may increase drowsiness

When using this product - Daytime

do not use more than directed

Stop use and ask a doctor if - Nighttime

  • •pain or cough 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
  • •cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.

Stop use and ask a doctor if - Daytime

  • •pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • •you get nervous, dizzy or sleepless
  • •fever gets worse or lasts more than 3 days
  • •redness or swelling is present
  • •new symptoms occur
  • •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. (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 - Nighttime

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

adults & children 12 yrs & over

30 mL (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

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

Directions - Daytime

  • •take only as directed - see Liver 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 insure correct dosing

Other information - Nighttime

  • •each 30 mL dose cup contains: sodium 38 mg
  • •store at 20-25°C (68-77°F)

Other information - Daytime

  • •each tablespoon contains: sodium 7 mg
  • •store at 20-25°C (68-77°F)

Inactive ingredients - Nighttime

alcohol, anhydrous citric acid, D&C yellow no. 10, FD&C green no. 3, FD&C yellow no. 6, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Inactive ingredients - Daytime

butylated hydroxyanisole, edetate disodium, FD&C yellow no. 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® Cold & Flu and Vicks® NyQuil® Cold & Flu

Cold & Flu

PAIN RELIEVER, FEVER REDUCER, COUGH SUPPRESSANT, NASAL DECONGESTANT, ANTIHISTAMINE†

Day

Non-Drowsy

Aches, Fever, Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

Nasal Congestion – Phenylephrine HCl

Alcohol Free

Antihistamine Free

Original Flavor

12 FL OZ (355 mL)

Night

Aches, Fever, Sore Throat – Acetaminophen

Cough – Dextromethorphan HBr

Sneezing, Runny Nose – Doxylamine Succinate

10% ALCOHOL

Original Flavor

12 FL OZ (355 mL)

†Nasal Decongestant in Day Time only, Antihistamine in Night Time only

Cold and Flu

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42507-702
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42507-702-02 1 in 1 KIT

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-03-07


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