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NDC 81522-0987-26 caring mill childrens cold and cough 2; 10; 5 mg/10mL; mg/10mL; mg/10mL Details
caring mill childrens cold and cough 2; 10; 5 mg/10mL; mg/10mL; mg/10mL
caring mill childrens cold and cough is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by FSA Store Inc.. The primary component is BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; 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: 81522-0987-26Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Brompheniramine
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
Related Packages: 81522-0987-26Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
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: 81522-0987-26Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 81522-0987 |
|---|---|
| Product ID | 81522-987_0970ab90-d982-4681-9162-52c893bcf114 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | caring mill childrens cold and cough |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 2; 10; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL |
| Substance Name | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | FSA Store Inc. |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 81522-0987-26 (81522098726)
| NDC Package Code | 81522-987-26 |
|---|---|
| Billing NDC | 81522098726 |
| Package | 1 BOTTLE in 1 CARTON (81522-987-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2021-09-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d3a7959c-a9cd-48ac-bb26-7544238fffc4 Details
Active ingredients (in each 10 mL)
Uses
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- temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and nasal congestion due to the common cold, hay fever or other upper respiratory allergies
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- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
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- runny nose
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- sneezing
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- itchy, watery eyes
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- itching of the nose or throat
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- temporarily restores freer breathing through the nose
Warnings
Do not use
- •
- 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.
- •
- to make a child sleepy
Ask a doctor before use if you have
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- heart disease
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- high blood pressure
- •
- thyroid disease
- •
- diabetes
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- trouble urinating due to an enlarged prostate gland
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
When using this product
- •
- do not use more than directed
- •
- may cause marked drowsiness
- •
- 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
Stop use and ask a doctor if
- •
- you get nervous, dizzy, or sleepless
- •
- symptoms do not get better within 7 days or are accompanied by fever
- •
- cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
Directions
Inactive ingredients
Principal Display Panel
Compare to the active ingredients of Children’s Dimetapp® Cold & Cough
Ages 6 years & Over
Children’s
Cold & Cough
Antihistamine, Brompheniramine Maleate
Cough Suppressant, Dextromethorphan HBr
Nasal Decongestant, Phenylephrine HCl
Red Grape Taste
Relieves:
Nasal Congestion, Runny Nose, Itchy, Watery Eyes, Coughing, Sneezing
Alcohol-Free
4 FL OZ (118 mL)
INGREDIENTS AND APPEARANCE
| CARING MILL CHILDRENS COLD AND COUGH
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution |
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| Labeler - FSA Store Inc. (049283340) |