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Drug Facts
Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408
Daytime Cough And Cold
FDA Label NDC 45014-158
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 45014-158). 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, otc - stop use, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active ingredient (in each 5 mL = 1 teaspoon) | Purpose |
|---|---|
| Dextromethorphan HBr, USP 5 mg | Cough suppressant |
| Phenylephrine HCl, USP 2.5 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.
Otc - Stop Use
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 - Ask Doctor/Pharmacist
Consult your pharmacist or health care provider for any appropriate, additional dosage delivery device necessary for use when a physician recommends a dose that is different than the doses that appear on the dosage delivery device that accompanies this product.
| Age (yr) | Dose (TSP) |
|---|---|
| under 4 yrs. | ask a doctor |
| 4 to under 6 | 1 TSP |
| 6 to under 12 | 2 TSP |
| or as directed by a doctor | |
| TSP = teaspoon | |
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Prompt medical attention is critical, even if you do not notice any signs or symptoms.
Other Information
- each teaspoon contains: sodium 2 mg
- store between 20°-25°C (68°-77°F)
- tamper evident: do not use if foil seal over the mouth of the bottle is torn, broken, or missing.
Directions
- may be given every 4 hours
- do not use more than 6 times in 24 hours
- use only enclosed dosing cup to dose this product. Do not use any other dosing device.
Questions?
877-434-2036
Inactive Ingredients
artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
Principal Display Panel - 118 Ml Bottle Label
ACCUDIAL®
Children's
Daytime
Cough and Cold
Dextromethorphan HBr (Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves Cough • Stuffy Nose
Earth-Friendly
Package!
For Ages 4 yrs to under 12 yrs
Tamper Evident
Compares to Children's Triaminic ®
Day Time Cold & Cough
CHERRY
FLAVOR
NDC 45014-158-04
4 FL. OZ. (118 mL)
Principal Display Panel (118 mL Bottle Label)
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