DAY-TIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

DAY-TIME by

Drug Labeling and Warnings

DAY-TIME by is a Otc medication manufactured, distributed, or labeled by DeMoulas Market Basket, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive Ingredients (in each 15 mL, 1 tablespoon)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCL 5 mg

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.

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

• more than 4 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.

Allergy Alert: Acetaminophen may causesevere skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reactions occurs, stop and seek medical help right away.

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

if the user is taking the blood thinning drug warfarin

When using this product

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

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

ask a health professional before use.

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.

Other information

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

Inactive ingredients

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

Questions?

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

1-877-798-5944

Product Label

MARKET BASKET ®

“MORE FOR YOUR DOLLAR”

*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:

INGREDIENTS AND APPEARANCE

DAY-TIME  COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-506
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 15 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg  in 15 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-506-28	354 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/12/2012

Labeler - DeMoulas Market Basket (007869647)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53942-506)