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daytime nighttime

HyVee Inc

Hy-Vee, Inc. Daytime and Nighttime Cold & Flu Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient for Nighttime (in each 15 mL tablespoon)

Acetaminophen 500 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Active ingredient for Daytime (in each 15 mL tablespoon)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose for Nighttime

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Purpose for Daytime

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

daytime nighttime Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion (Daytime only)
  • sore throat
  • cough due to minor throat and bronchial irritation
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing (Nighttime only)

Warnings

Liver warning: These products contain acetaminophen. Severe liver damage may occur if:

  • adult takes more than 4 doses in 24 hours (Nighttime) or more than 6 doses in 24 hours (Daytime), which is the maximum daily amount
  • child takes more than 5 doses in 24 hours (Daytime)
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks every day while using these products

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or 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.
  • to make a child sleepy

Ask a doctor before use if you have

  • high blood pressure (Daytime only)
  • heart disease (Daytime only)
  • diabetes (Daytime only)
  • thyroid disease (Daytime only)
  • trouble urinating due to an enlarged prostate gland
  • liver disease
  • 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 (Nighttime only)
  • glaucoma (Nighttime only)
  • a sodium-restricted diet (Nighttime only)

Ask a doctor or pharmacist before use if you are

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

When using these products

  • do not use more than directed

In addition, when using Nighttime:

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

Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless (Daytime only)
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • pain, nasal congestion or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • 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. 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 recommended – see Liver warning
  • take Nighttime or Daytime
  • use dose cup

Nighttime Liquid

  • do not exceed 4 doses per 24 hours
adults and children 12 years and over 30 mL (2 TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use

Daytime Liquid

  • do not exceed 5 doses (children) or 6 doses (adults) per 24 hours
adults and children 12 years and over 30 mL (2 TBSP) every 4 hours
children 6 to under 12 years 15 mL (1 TBSP) every 4 hours
children 4 to under 6 years ask a doctor
children under 4 years do not use
  • when using other Daytime or Nighttime products, carefully read each label to insure correct dosing

daytime nighttime Other information

  • each TBSP of Nighttime contains: sodium 18 mg
  • each TBSP of Daytime 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

Daytime butylated hydroxyanisole, edetate disodium, FD&C yellow no. 6, flavors, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions or comments?

1-800-719-9260

Principal Display Panel

DO NOT USE IF PRINTED NECKBAND IS BROKEN OR MISSING

SEE NEW WARNINGS INFORMATION

Compare to Vicks® DayQuil® active ingredients

Daytime Cold & Flu

Non-Drowsy

Multi-Symptom Relief

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Phenylephrine HCl - Nasal Congestion

ALCOHOL FREE

ANTIHISTAMINE FREE

Pain Reliever, Fever Reducer, Cough Suppressant, Nasal Decongestant

SEE NEW WARNINGS INFORMATION

Compare to Vicks® NyQuil® active ingredients

Nighttime Cold & Flu

Original Flavor

Multi-Symptom Relief

Acetaminophen - Aches, Fever

Dextromethorphan HBr - Cough

Doxylamine succinate - Sneezing, Runny Nose

10% ALCOHOL

Pain Reliever, Fever Reducer, Cough Suppressant, Antihistamine

daytime nighttime
Daytime and Nighttime Cold & Flu Carton Image 1 Daytime and Nighttime Cold & Flu Carton Image 2 Daytime and Nighttime Cold & Flu Carton Image 3 Daytime and Nighttime Cold & Flu Carton Image 4 Daytime and Nighttime Cold & Flu Carton Image 5

daytime nighttime

Acetaminophen, Dextromethorphan HBr, Doxylamine succinate, Phenylephrine HCl KIT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42507-912
Route of Administration DEA Schedule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42507-912-01 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2006-08-04


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Be sure to consult your doctor before taking any medication!
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