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NDC 62011-0257-01 health mart childrens allergy plus congestion 12.5; 5 mg/5mL; mg/5mL Details
health mart childrens allergy plus congestion 12.5; 5 mg/5mL; mg/5mL
health mart childrens allergy plus congestion is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Diphenhydramine is used to relieve red, irritated, itchy, watery eyes; sneezing; and runny nose caused by hay fever, allergies, or the common cold. Diphenhydramine is also used to relieve cough caused by minor throat or airway irritation. Diphenhydramine is also used to prevent and treat motion sickness, and to treat insomnia (difficulty falling asleep or staying asleep). Diphenhydramine is also used to control abnormal movements in people who have early stage parkinsonian syndrome (a disorder of the nervous system that causes difficulties with movement, muscle control, and balance) or who are experiencing movement problems as a side effect of a medication. Diphenhydramine will relieve the symptoms of these conditions but will not treat the cause of the symptoms or speed recovery. Diphenhydramine should not be used to cause sleepiness in children. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 62011-0257-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Diphenhydramine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
Related Packages: 62011-0257-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 62011-0257 |
|---|---|
| Product ID | 62011-0257_a1c04fc7-84e4-4e78-b54c-e5a2b91b3be7 |
| Associated GPIs | |
| GCN Sequence Number | 062643 |
| GCN Sequence Number Description | phenylephrine/diphenhydramine SOLUTION 5-12.5MG/5 ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 98417 |
| HICL Sequence Number | 019892 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/DIPHENHYDRAMINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | health mart childrens allergy plus congestion |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | diphenhydramine hcl, phenylephrine hcl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 12.5; 5 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Strategic Sourcing Services LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 62011-0257-01 (62011025701)
| NDC Package Code | 62011-0257-1 |
|---|---|
| Billing NDC | 62011025701 |
| Package | 1 BOTTLE in 1 CARTON (62011-0257-1) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2018-02-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8039a066-a407-4ee3-919a-57b9bfdc5568 Details
Uses
- •
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- •
- runny nose
- •
- sneezing
- •
- itchy, watery eyes
- •
- itching of the nose or throat
- •
- nasal congestion
- •
- stuffy nose
- •
- temporarily relieves these symptoms due to the common cold:
- •
- runny nose
- •
- sneezing
- •
- nasal congestion
- •
- stuffy nose
- •
- temporarily relieves sinus congestion and pressure
Do not use
- •
- to make a child sleepy
- •
- with any other product containing diphenhydramine, even one used on skin
- •
- if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
Directions
- •
- find right dose on chart below
- •
- mL = milliliter
- •
- take every 4 hours
- •
- do not take more than 6 doses in 24 hours
|
Age (yr) |
Dose (mL) |
|
children under 4 years |
do not use |
|
children 4 to 5 years |
do not use unless directed by a doctor |
|
children 6 to 11 years |
5 mL |
|
adults and children 12 years and over |
10 mL |
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
Inactive ingredients
Package/Label Principal Display Panel
Compare to Children’s Benadryl® Allergy Plus Congestion active ingredients
ORAL SOLUTION
Children’s Allergy Plus Congestion
Antihistamine (Diphenhydramine HCl)
Nasal Decongestant (Phenylephrine HCl)
Relieves:
Runny Nose; Sneezing
Itchy, Watery Eyes; Itchy Throat or Nose
Sinus Congestion; Stuffy Nose
4 Hours/Dose • Sugar Free
Gluten Free • Alcohol Free
GRAPE FLAVOR
4 Fl oz (118 mL)
INGREDIENTS AND APPEARANCE
| HEALTH MART CHILDRENS ALLERGY PLUS CONGESTION
diphenhydramine hcl, phenylephrine hcl solution |
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| Labeler - Strategic Sourcing Services LLC (116956644) |