RxNorm Names
Review RxNorm Normal Forms
PEDIACARE CHILDRENS ALLERGY AND COLD
(diphenhydramine hydrochloride and phenylephrine hydrochloride)
liquid
[Blacksmith Brands, Inc.]
Permanent Link:
http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e349f954-c331-4493-ae0b-543af66bd1ae| Category | DEA Schedule | Marketing Status |
|---|---|---|
| HUMAN OTC DRUG LABEL | OTC monograph final |
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- nasal congestion
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose
- sneezing
- nasal congestion
- cough
Warnings
Do not use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
- 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 your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product
Ask a doctor before use
if the child has
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- persistent or chronic cough such as occurs with asthma
- cough accompanied by excessive phlegm (mucus)
- a breathing problem such as chronic bronchitis
- glaucoma
When using this product
-
do not exceed recommended dose
- excitability may occur, especially in children
- marked drowsiness may occur
- sedatives and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not improve within 7 days or occur with a fever
- cough gets worse or lasts for more than 7 days
- cough tends to come back or occurs with fever, rash or headache that lasts
These could be signs of a serious condition.
Directions
- find right dose on chart below
- use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- take every 4 hours
- do not take more than 6 doses in 24 hours
| Age (yr) | Dose (tsp) |
| Under 4 years | Do not use |
| 4 to 5 years | Do not use unless directed by a doctor |
| 6 to 11 years | 1 teaspoonful |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
- each teaspoon contains: sodium 10 mg
- store between 20-25°C (68-77°F). Protect from light.
-
do not use if bottle wrap, or foil inner seal imprinted “Safety Seal®” is broken or missing
- see bottom panel for lot number and expiration date
Store in outer carton until contents are used.
| PEDIACARE CHILDRENS ALLERGY AND COLD
diphenhydramine hydrochloride and phenylephrine hydrochloride liquid |
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| Labeler - Blacksmith Brands, Inc. (021411299) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
| Trillium Healthcare Products, Inc. | 255426306 | MANUFACTURE | |
Revised: 08/2010
Document Id: f38b1e3b-e0ed-4d53-b892-036bf21bf6ff
Set id: e349f954-c331-4493-ae0b-543af66bd1ae
Version: 3
Effective Time: 20100806
Blacksmith Brands, Inc.
