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NDC 69842-0823-30 severe cold 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL Details
severe cold 650; 20; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
severe cold is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. 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: 69842-0823-30Last 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: 69842-0823-30Last 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: 69842-0823-30Last 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: 69842-0823-30Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 69842-0823 |
|---|---|
| Product ID | 69842-823_79ae440c-e1fd-419f-a635-a5ac72792844 |
| 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 | severe cold |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 400; 10 |
| Active Ingredient Units | mg/20mL; mg/20mL; mg/20mL; mg/20mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | CVS Pharmacy |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 69842-0823-30 (69842082330)
| NDC Package Code | 69842-823-30 |
|---|---|
| Billing NDC | 69842082330 |
| Package | 180 mL in 1 BOTTLE (69842-823-30) |
| Marketing Start Date | 2018-08-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL de5470c0-70ab-4487-9e21-e0b0f2effa71 Details
Active ingredients (in each 20 mL)
Uses
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- temporarily relieves these common cold and flu symptoms:
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- cough
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- nasal congestion
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- minor aches and pains
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- sore throat
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- headache
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- stuffy nose
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- sinus congestion and pressure
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- temporarily reduces fever
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- rash
If a 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- 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.
- •
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
- •
- heart disease
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- diabetes
- •
- high blood pressure
- •
- thyroid disease
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
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- nervousness, dizziness or sleeplessness occur
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- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- •
- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
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- do not take more than directed (see Overdose warning)
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- do not take more than 5 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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- adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours
- •
- children under 12 years of age: do not use
Other information
Inactive ingredients
Package/Label Principal Display Panel
CVS Health™
Compare to the active ingredients in Mucinex® Fast-Max® Severe Cold
MAXIMUM STRENGTH
Severe Cold
Acetaminophen – Pain reliever, Fever reducer
Dextromethorphan HBr – Cough suppressant
Guaifenesin – Expectorant
Phenylephrine HCl – Nasal decongestant
MULTI-SYMPTOM
Controls cough
Thins & loosens mucus
Relieves nasal & chest congestion
Relieves aches, fever & sore throat
FOR AGES 12+
6 FL OZ (180 mL)
INGREDIENTS AND APPEARANCE
| SEVERE COLD
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution |
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| Labeler - CVS Pharmacy (062312574) |