Other
Drug Facts
Manufactured for
ACCUDIAL
PHARMACEUTICAL, INC.
AccurateDose.com
Palm Beach Gardens, FL 33410
Distributed by:
LeSaint Logistics
Corporate Headquarters
2570 Northwest Parkway
Elgin, IL 60124
Daytime Cough And Cold
FDA Label NDC 45014-152
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Accudial Pharmaceutical, Inc. for the product Daytime Cough And Cold (NDC 45014-152). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - do not use, otc - ask doctor, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredients (in each 5 mL, 1 teaspoonful) | Purposes |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Phenylephrine HCl, USP 1.25 mg | Nasal decongestant |
Uses
- temporarily relieves
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation as may occur with a cold
Otc - Do Not Use
Do not use in a child under 4 years of age
in a child who is 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 the child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
Otc - Ask Doctor
Ask a doctor before use if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
When Using This Product
- do not exceed recommended dosage
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occurs
- symptoms do not improve within 7 days or occur with a fever
- cough persists for more than 7 days, comes back, or occurs with a fever, rash, or persistent headache. These could be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- May be given every 6 hours. Do not give more than 4 doses in 24 hours unless directed by a doctor.
| Children under 4 years of age | do not use |
| Children 4 to under 6 years of age | 1-1½ tsp. (5-7.5 mL) |
| Children 6 to under 12 years of age | 1½-3 tsp. (7.5-15 mL) |
Other Information
- each teaspoon contains: sodium 2 mg
- store at controlled room temperature 20°-25°C (68°-77°F)
Inactive Ingredients
Artificial Flavor, Benzoic Acid, Citric Acid, EDTA Disodium, FD&C Red #40, Purified Water, Sodium Citrate, Sodium Saccharin, Sorbitol.
Otc - Questions
Question Image (Daytime 01)
Principal Display Panel - 118 Ml Bottle Carton
CHILDREN'S
ACCUDIAL
ROTATING DOSING LABEL
Daytime
Cough & Cold
ACCURATE DOSING
BY WEIGHT
Dextromethorphan HBr
(Cough Suppressant)
Phenylephrine HCl
(Nasal Decongestant)
Cough
Stuffy Nose
For Ages 4 to under 12
Compares to the active
ingredients in Children's
Triaminic® Day Time
Cold & Cough.
CHERRY
FLAVOR
4 FL.OZ.
(118 mL)
NDC 45014-152-04
Principal Display Panel (118 mL Bottle Carton)
* Please review the disclaimer below.
