FDA Label for Nite Time Cold And Cough
View Indications, Usage & Precautions
Nite Time Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Accudial Pharmaceutical, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: AccuDial® Pharmaceutical, Inc.
Palm Beach Gardens, FL 33408
Otc - Purpose
| Active ingredient (in each 5 mL = 1 teaspoon) | Purpose |
|---|---|
| Diphenhydramine HCl, USP 6.25 mg | Antihistamine/Cough suppressant |
| Phenylephrine HCl, USP 2.5 mg | Nasal decongestant |
Uses
Temporarily relieves
- sneezing
- itchy nose or throat
- runny nose
- itchy, watery eyes due to hay fever
- 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 6 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
- with any other product containing diphenhydramine, even one used on skin
- for the purpose of making your child sleepy.
Otc - Ask Doctor
Ask a doctor before use if the child has heart disease
- high blood pressure thyroid disease
- diabetes
- glaucoma cough that occurs with too much phlegm (mucus)
- chronic cough that lasts, or as occurs with asthma
- a breathing problem such as chronic bronchitis.
Otc - Ask Doctor/Pharmacist
Ask a pharmacist before use if the child is taking sedatives or tranquilizers.
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) |
|---|---|
| TSP = teaspoon | |
| under 6 yrs. | ask a doctor |
| 6 to under 12 | 2 TSP |
| or as directed by a doctor | |
When Using This Product
- do not exceed recommended dosage marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness excitability may occur, especially in children.
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 - 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 9 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.
Inactive Ingredients
artificial flavor, benzoic acid, citric acid, EDTA disodium dihydrate, FD&C blue #1, FD&C red #40, propylene glycol, purified water, sodium citrate, sodium saccharin, sorbitol.
Questions?
877-434-2036
Principal Display Panel - 118 Ml Bottle Label
ACCUDIAL®
Children's
Nite Time
Cold and Cough
Diphenhydramine
(Antihistamine/Cough Suppressant)
Phenylephrine HCl (Nasal Decongestant)
Relieves Cough • Runny Nose
Stuffy Nose • Itchy Throat
Earth-Friendly
Package!
For Ages 6 yrs to under 12 yrs
Tamper Evident
Compares to Children's Triaminic®
Night Time Cold & Cough
GRAPE
FLAVOR
NDC 45014-159-04
4 FL. OZ. (118 mL)
* Please review the disclaimer below.