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DAY-TIME

DeMoulas Market Basket
AptaPharma Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredients

Drug Facts

Active Ingredients (in each 15 mL, 1 tablespoon)     

 
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCL 5 mg

Purpose

          Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Keep out of reach of children

Keep this and all drugs out of the reach of children.

DAY-TIME Uses

Uses

temporarily relieves these common cold/flu symptoms:

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

Warnings

Warnings


Liver warning:

This product contains acetaminophen. Severe liver damage may occur if adult/child takes

  • more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks everyday while using this product

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

Do not use

  • 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 two weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product
  • with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacists.

Ask a doctor before use if you have Ask a doctor or pharmacist

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • thyroid disease
  • diabetes
  • high blood pressure
  • trouble urinating due to enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm (mucus)
Ask a doctor or pharmacist before use


When using this product

When using this product

  • do not use more than directed (see overdose warning)
  • avoid alcoholic drinks

Stop use and ask a doctor if

Stop use and ask a doctor if

  • you get nervous, dizzy, or sleepless
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition.

If pregnant of breast-feeding

If pregnant or breast-feeding

ask a health professional before use.

Overdose Warning

Overdose Warning:

Taking more than the recommended dose (overdose) could cause serious health problems, including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions

  • take only as recommended (see overdose warning)
  • use dosage cup or tablespoon (TBSP)
  • do not exceed 4 doses per 24 hours



age                                                                                                         dose
adults and children 12 years and over                                                        30 mL (2 TBSP) every 4 hours
children 6 years to under 12 years                                                             15 mL (1 TBSP) every 4 hours
children 4 years to  under 6 years                                                              ask a doctor
children under 4 years                                                                              do not use

  • When using Day Time and Night Time products, carefully read each label to ensure correct dosing.

DAY-TIME Other information

Other information

  • sodium content per tablespoon: 10 mg
  • store at room temperature

Inactive ingredients

Inactive ingredients

citric acid, FD and C Yellow #6, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucrose

Questions?

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

“MORE FOR YOUR DOLLAR”
MARKET BASKET ®

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®
DAYQUIL ®

DAY-TIME
COLD AND FLU RELIEF

Acetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Phenylephrine HCL ……. Nasal Decongestant

12 FL OZ (354 ML)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

*This product is not manufactured or distributed by Proctor and Gamble, owner of the registered trademark Vicks® Dayquil®.

DISTRIBUTED BY DEMOULAS SUPERMARKETS INC.
875 EAST STREET
TEWKSBURY, MA 01876

LR-036

LOT:                EXP:

DAY-TIME

DAY-TIME

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53942-506
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
Phenylephrine Hydrochloride PHENYLEPHRINE 5 mg

Inactive Ingredients

Ingredient Name Strength
CITRIC ACID MONOHYDRATE
FD&C YELLOW NO. 6
GLYCERIN
propylene glycol
water
saccharin sodium
SODIUM BENZOATE
SUCROSE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53942-506-28 354 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2012-09-12


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