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| Product NDC Code | 70677-1012 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Foster and thrive childrens allergy relief |
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| Type | Brand | ||||||
| Pharm Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | LIQUID | ||||||
| RxCUI drug identifier | 1049906 | ||||||
| Application Number | part341 | ||||||
| Labeler Name | Strategic Sourcing Services LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT(S) Diphenhydramine HCl 12.5 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DIRECTIONS find right dose on chart below mL=milliliter measure only with dosing cup provided do not use dosing cup with other products take every 4 to 6 hours, or as directed by a doctor do not take more than 6 doses in 24 hours AGE(yr) DOSE(mL) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 5 mL to 10 mL
| children under 2 years | do not use |
| children 2 to 5 years | do not use unless directed by a doctor |
| children 6 to 11 years | 5 mL to 10 mL |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS carboxymethylcellulose sodium, citric acid, flavors, glycerin, purified water , saccharin sodium, sodium benzoate, sorbitol.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.USE(S) temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat
Purpose
Information about the drug product’s indications for use.PURPOSE Antihistamine
Spl product data elements
Usually a list of ingredients in a drug product.Foster and Thrive Childrens Allergy Relief Diphenhydramine HCl DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS CITRIC ACID GLYCERIN SACCHARIN SODIUM WATER SODIUM BENZOATE SORBITOL
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 70677-1012-2 COMPARE TO CHILDREN'S BENADRYL® ORAL SOLUTION ACTIVE INGREDIENT* Foster & Thrive TM Children's Allergy Relief Diphenhydramine HCl oral solution, 12.5 mg/5ml ANTIHISTAMINE Dye Free 4-6 Hours/Dose Relief of: Runny Nose Itchy Watery Eyes Sneezing Itchy Throat or Nose 2+ Ages CHERRY FLAVOR DOSING CUP INCLUDED 8FL OZ(236 mL) NDC 70677-1012-1 COMPARE TO CHILDREN'S BENADRYL ® ORAL SOLUTION ACTIVE INGREDIENT* Foster & Thrive TM Children's Allergy Relief Diphenhydramine HCl oral solution, 12.5 mg/5ml ANTIHISTAMINE Dye Free 4-6 Hours/Dose Relief of: Runny Nose Itchy Watery Eyes Sneezing Itchy Throat or Nose 2+Ages CHERRY FLAVOR DOSING CUP INCLUDED 4FL OZ(118 mL) 549ft8label 549ft8carton 549ft4label 549ft4carton
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.ASK A DOCTOR BEFORE USE IF THE CHILD HAS glaucoma a breathing problem such as chronic bronchitis
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.ASK A DOCTOR OR PHARMACIST BEFORE USE IF THE CHILD IS taking sedatives or tranquilizers
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.DO NOT USE to make a child sleepy with any other product containing diphenhydramine, even one used on skin
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFORMATION each 5 mL contains: sodium 5 mg dosing cup provided store between 20°-25°C(68°-77°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS OR COMMENTS Call 833-358-6431 Monday to Friday 9:00 am to 7:00 pm EST
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.WHEN USING THIS PRODUCT sedatives and tranquilizers may increase drowsiness marked drowsiness may occur excitability may occur, especially in children
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.WARNINGS .
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API