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NDC 62011-0443-01 Dibromm Cold and Allergy Relief 2; 5 mg/10mL; mg/10mL Details
Dibromm Cold and Allergy Relief 2; 5 mg/10mL; mg/10mL
Dibromm Cold and Allergy Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Strategic Sourcing Services LLC. The primary component is BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Brompheniramine relieves red, irritated, itchy, watery eyes; sneezing; and runny nose caused by allergies, hay fever, and the common cold. Brompheniramine helps control symptoms, but does not treat the cause of the symptoms or speed recovery. Brompheniramine should not be used to cause sleepiness in children. Brompheniramine 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: 62011-0443-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Brompheniramine
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: 62011-0443-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 62011-0443 |
|---|---|
| Product ID | 62011-0443_298ef643-063e-44d1-abd8-de5f6e73d838 |
| Associated GPIs | 43993002200930 |
| GCN Sequence Number | 061050 |
| GCN Sequence Number Description | brompheniramine/phenylephrine SOLUTION 1-2.5 MG/5 ORAL |
| HIC3 | Z2N |
| HIC3 Description | 1ST GEN ANTIHISTAMINE AND DECONGESTANT COMBINATION |
| GCN | 27207 |
| HICL Sequence Number | 000443 |
| HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Dibromm Cold and Allergy Relief |
| Proprietary Name Suffix | childrens |
| Non-Proprietary Name | Brompheniramine maleate, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 2; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL |
| Substance Name | BROMPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Strategic Sourcing Services LLC |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], 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 62011-0443-01 (62011044301)
| NDC Package Code | 62011-0443-1 |
|---|---|
| Billing NDC | 62011044301 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (62011-0443-1) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2019-01-31 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.01963 |
| Pricing Unit | ML |
| Effective Date | 2023-01-18 |
| NDC Description | HM CHILD'S DIBROMM COLD-ALLGY |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-01-10 |
Standard Product Labeling (SPL)/Prescribing Information SPL 61eca862-f9fb-4cf3-9653-b6a7010627dd Details
Uses
- temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
- temporarily relieves these symptoms due to hay fever (allergic rhinitis)
- runny nose
- itchy, watery eyes
- sneezing
- itching of the nose or throat
- temporarily restores freer breathing through the nose
Warnings
Do not use
- to sedate a child or to make a child sleepy
- 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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are
- taking any other oral nasal decongestant or stimulant
- taking sedatives or tranquilizers
When using this product
- do not use more than directed
- drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
| age | dose |
| adults and children 12 years and over | 20 mL every 4 hours |
| children 6 to 11 years | 10 mL every 4 hours |
| children under 6 years | do not use |
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Children's Dimetapp® cold and allergy†
Children's
Dibromm Cold & Allergy
Brompheniramine Maleate 2 mg Antihistamine
Phenylephrine HCL 5 mg Nasal Decongestant
Itchy, watery eyes • Runny nose
• Sneezing • Stuff nose
• Itching of the nose or throat
For ages 6 years and over
Alcohol free
FL OZ (mL)
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by McKesson
6555 State Highway 161 Irving, TX 75039
heartmart.com
INGREDIENTS AND APPEARANCE
| DIBROMM COLD AND ALLERGY RELIEF
CHILDRENS
brompheniramine maleate, phenylephrine hcl liquid |
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| Labeler - Strategic Sourcing Services LLC (116956644) |