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NDC 76281-0325-24 Childrens Cough and Cold CF 10; 100; 5 mg/10mL; mg/10mL; mg/10mL Details
Childrens Cough and Cold CF 10; 100; 5 mg/10mL; mg/10mL; mg/10mL
Childrens Cough and Cold CF is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
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: 76281-0325-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Dextromethorphan
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a class of medications called expectorants. It works by thinning the mucus in the air passages to make it easier to cough up the mucus and clear the airways.
Related Packages: 76281-0325-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Guaifenesin
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: 76281-0325-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 76281-0325 |
|---|---|
| Product ID | 76281-325_0bf0ab99-a0c5-44d1-8d44-51dff5c87dcb |
| 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 | Childrens Cough and Cold CF |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 10; 100; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | AptaPharma 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 | 2022-12-31 |
Package
Package Images
NDC 76281-0325-24 (76281032524)
| NDC Package Code | 76281-325-24 |
|---|---|
| Billing NDC | 76281032524 |
| Package | 1 BOTTLE in 1 CARTON (76281-325-24) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2021-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 0c6b81e4-d951-4e09-ab72-f1e7668b9a92 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Do not use if you are now taking aprescription
monoamine oxidase inhibitor (MAOI) (certain drugs for
depression, psychiatric, or emotional conditions, or
Parkinson's diseases) 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
• diabetes
• high blood pressure
• thyroid disease
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• cough that lasts or is chronic such as 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
When using this product
• do not use more than directed
Stop use and ask a doctor if
• nervousness, dizziness, or sleeplessness occurs
• symptoms do not get better within 7 days or are
accompanied by fever
• cough lasts more than 7 days, comes back, or is
accompanied by fever, rash, or persistent headache.
These could be signs of a serious condition.
If pregnant or breast feeding, ask aheaith professional
before use
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions
• do not take more than 6 doses in any 24-hour period
• measure only with dosing cup provided
• mL = milliliter
| children under 4 years | do not use |
| children 4 to under 6 years | 5 mL every 4 hours |
| children 6 to under 12 years | 10 mL every 4 hours |
| adults and children 12 years and over | 20 mL every 4 hours |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Product Labeling
CVS
Health®
Compare to the active
ingredients in Children's
Robitussin® Cough
& Cold CF*
Non-drowsy
NDC 76281-325-24
Children's
Cough
& Cold CF
Ages 4+
Grape Flavor
4 FL OZ (118 mL)
Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
©2021 CVS/pharmacy
CVS.COM 1-800-SHOP-CVS BX-128 Rev01
*This product is not manufactured or distributed by
Pfizer, distributor of Children's Robitussin® Cough
& Cold CF.
res
INGREDIENTS AND APPEARANCE
| CHILDRENS COUGH AND COLD CF
dextromethorphan hbr, guaifenesin, phenylephrine hcl liquid |
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| Labeler - AptaPharma Inc. (790523323) |
| Registrant - AptaPharma Inc. (790523323) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| AptaPharma Inc. | 790523323 | manufacture(76281-325) | |