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NDC 76281-0321-24 Childrens Mucus Relief Cough, Cold and Sore Throat 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL Details
Childrens Mucus Relief Cough, Cold and Sore Throat 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
Childrens Mucus Relief Cough, Cold and Sore Throat is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by AptaPharma Inc.. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 76281-0321-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 76281-0321-24Last 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: 76281-0321-24Last 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: 76281-0321-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 76281-0321 |
|---|---|
| Product ID | 76281-321_6f8b8906-e1dc-46b3-a76b-941f1df3de5a |
| 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 Mucus Relief Cough, Cold and Sore Throat |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 200; 5 |
| Active Ingredient Units | mg/10mL; mg/10mL; mg/10mL; mg/10mL |
| Substance Name | ACETAMINOPHEN; 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 76281-0321-24 (76281032124)
| NDC Package Code | 76281-321-24 |
|---|---|
| Billing NDC | 76281032124 |
| Package | 1 BOTTLE in 1 CARTON (76281-321-24) / 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 fed91de5-baf5-4acd-b200-6cd2386c8775 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Warnings
Liver warning This product contains
acetaminophen. Severe liver damage may occur if
your child takes • more than 5 doses in 24 hours,
which is the maximum daily amount • with other
drugs containing acetaminophen
Allery Alert: Acetaminophen may cause severe
skin reactions. Symptoms may include: • skin
reddening • blisters • rash. If skin reaction
occurs, stop use and seek medical help right away.
Sore throat warning If sore throat is severe,
persists for more than 2 days, is accompanied or
followed by fever, headache, rash, nausea
or vomiting, consult a doctor promptly.
Do not use • with any other drug containing
acetaminophen (prescription or nonprescription). If
you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
• in a child who is 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 child's prescription drug
contains an MAOI, ask a doctor or pharmacist before
giving this product.
Ask a doctor before use if your child has
• liver disease • heart disease
• high blood pressure • thyroid disease
• diabetes
• a breathing problem such as chronic bronchitis
• persistent or chronic cough such as occurs with asthma
• cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if
• your child is taking the blood thinning drug warfarin
When using this product • do not use more than
directed (see Overdose warning)
Stop use and ask a doctor if
• redness or swelling is present
• nervousness, dizziness or sleeplessness occur
• new symptoms occur
• pain, nasal congestion or cough gets worse or lasts
more than 5 days
• fever gets worse or lasts more than 3 days
• cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Directions • do not use more than directed
(see overdose warning)
• shake well before using
• do not use more than 5 doses in any 24-hour period
• if needed, repeat dose every 4 hours while symptoms last
• do not use more than 5 days unless directed by a doctor
• use dosage cup
| Age | Dose |
| Children 6 to under 12 years of age |
10 mL every 4 hours |
| Children under 6 years of age | do not use |
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
Product Labeling
CVS
Health®
Compare to the active
ingredients in Children's
Mucinex® Cold, Cough
& Sore Throat*
NDC 76281-321-24
Children's
Mucus Relief
Cough, Cold
& Sore Throat
Acetaminophen 325 mg
Pain reliever, Fever reducer
Dextromethorphan HBr 10 mg
Cough Suppressant
Guaifenesin 200 mg
Expectorant
Phenylephrine HCI 5 mg
Nasal decongestant
Berry Blast Flavor Liquid
Ages 6+
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-127 Rev01
V-37134
*This product is not manufactured or distributed by Reckitt
Benckiser, distributor of Children's Mucinex® Cold, Cough
& Sore Throat.
DO NOT USE IF PRINTED SEAL UNDER CAP
IS TORN OR MISSING
res
INGREDIENTS AND APPEARANCE
| CHILDRENS MUCUS RELIEF COUGH, COLD AND SORE THROAT
acetaminophen, 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(76281-321) | |