Label: DAYTIME NON-DROWSY COLD/FLU- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquid
- NDC Code(s): 57243-506-25
- Packager: Salado Sales, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug FactsActive Ingredients (in each 15 mL, 1 tablespoon)
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver Warning: The product contains acetaminophen. Severe liver
damage may occur if ■ adult takes more than 4doses (30 mL each)
in 24 hours, which is the maximum daily amount for this product ■
child takes more than 4 doses (15 mL each) in 24 hours, which is the
maximum daily amount for this product ■ taken with other drugs
containing acetaminophen ■ adult has 3 or more alcoholic drinks
every day while using the productAllergy 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.
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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 DOCTOR/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
-
STOP USE
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. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
OVERDOSAGE
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. -
DOSAGE & ADMINISTRATION
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 SAFETY INFORMATION
- INACTIVE INGREDIENT
-
Day Time product label
COMPARE TO
VICKS® DAYQUIL®
ACTIVE INGREDIENTS
CVP®
DAY TIME
NON-DROWSY COLD/FLU RELIEF
Acetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Phenylephrine HCL ……. Nasal Decongestant6 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®.Questions? Call weekdays from 9:30am
to 4:30pm EST at 1-877-798-5944LR-038 Rev 03
Distributed by:
Salado Sales, Inc.
P.O. Box 6115
Temple, Tx 76503
www.saladosales.com
LOT: EXP:
RES
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INGREDIENTS AND APPEARANCE
DAYTIME NON-DROWSY COLD/FLU
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride liquidProduct 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 Drug M013 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)