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NDC 70677-0121-01 Cold and Cough Relief 2; 10; 5 mg/10mL; mg/10mL; mg/10mL Details
Cold and Cough Relief 2; 10; 5 mg/10mL; mg/10mL; mg/10mL
Cold and Cough 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; 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: 70677-0121-01Last 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: 70677-0121-01Last 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: 70677-0121-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 70677-0121 |
|---|---|
| Product ID | 70677-0121_480bf717-f59e-4da4-8ced-7fb7a6d8080a |
| Associated GPIs | 43995803080910 |
| GCN Sequence Number | 060622 |
| GCN Sequence Number Description | brompheniram/phenylephrine/DM SOLUTION 1-2.5-5/5 ORAL |
| HIC3 | B3R |
| HIC3 Description | NON-OPIOID ANTITUS-1ST GEN.ANTIHISTAMINE-DECONGEST |
| GCN | 26808 |
| HICL Sequence Number | 035368 |
| HICL Sequence Number Description | BROMPHENIRAMINE MALEATE/PHENYLEPHRINE HCL/DEXTROMETHORPHAN |
| Brand/Generic | Generic |
| Proprietary Name | Cold and Cough Relief |
| Proprietary Name Suffix | children |
| Non-Proprietary Name | Brompheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| 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 | Strategic Sourcing Services LLC |
| 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 70677-0121-01 (70677012101)
| NDC Package Code | 70677-0121-1 |
|---|---|
| Billing NDC | 70677012101 |
| Package | 1 BOTTLE, PLASTIC in 1 BOX (70677-0121-1) / 118 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2020-10-30 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.01699 |
| Pricing Unit | ML |
| Effective Date | 2022-11-23 |
| NDC Description | SM CHILDREN'S COLD-COUGH LIQ |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2022-11-23 |
Standard Product Labeling (SPL)/Prescribing Information SPL ae69e04f-577a-4326-b78e-c9441f4f53b5 Details
Active ingredients (in each 10 mL)
Uses
- 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
- temporarily relieves these symptoms due to hay fever (allergic rhinitis):
- runny nose
- sneezing
- itchy, watery eyes
- 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
- cough that occurs with too much phlegm (mucus)
- a breathing problem or persistent or chronic cough that lasts such occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- marked 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 a 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- mL = milliliter
| 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 |
Other information
Inactive ingredients
Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S DIMETAPP® COLD & COUGH
Children's
Cold & Cough Relief
Relieves itchy, watery eyes, cough, runny nose, sneezing, stuffy nose, itching of the nose or throat
For ages 6 years and over
Alcohol-free
BROMPHENIRAMINE MALEATE 2 MG
ANTIHISTAMINE
DEXTROMETHORPHAN HBr 10 MG
COUGH SUPPRESSANT
PHENYLEPHRINE HCl 5 MG
NASAL DECONGESTANT
GRAPE FLAVOR
fl oz (mL)
Dosing Cup Included
*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Children's Dimetapp® Cold & Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
Distributed by McKesson Corp.
6555 State Highway 161 Irving, TX 75039
INGREDIENTS AND APPEARANCE
| COLD AND COUGH RELIEF
CHILDREN
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid |
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| Labeler - Strategic Sourcing Services LLC (116956644) |