DAYTIME NON-DROWSY COLD/FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Daytime by

Drug Labeling and Warnings

Daytime by is a Otc medication manufactured, distributed, or labeled by Salado Sales, Inc., 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

     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

Warnings


Liver warning:

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

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using this product

Allergy Alert

Acetaminophen may cause severe skin reactions. Symptoms may include:

• skin reddening
• blisters
• rash.

If a skin reaction occurs, stop use 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

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

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

Other information

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

Inactive ingredients

 citric acid, FD&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

Day Time product label

*COMPARE TO THE ACTIVE INGREDIENTS IN VICKS ®
DAYQUIL ®

CVP
CONSUMER VALUE PRODUCTS

DAYTIME

NON-DROWSY COLD/FLU RELIEF

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

6 FL OZ (177 mL)

Failure to follow these warnings could result in serious consequences

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN

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

LR-038 Rev 02

Distributed by:
Salado Sales, Inc.
P.O. Box 6115
Temple, Tx 76503
www.saladosales.com

LOT:       EXP:

INGREDIENTS AND APPEARANCE

DAYTIME  NON-DROWSY COLD/FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57243-506
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: 57243-506-25	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/05/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/05/2012

Labeler - Salado Sales, Inc. (009830555)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(57243-506)