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NDC 59779-0926-08 Flu and Severe Cold 650; 20; 10 mg/30mL; mg/30mL; mg/30mL Details
Flu and Severe Cold 650; 20; 10 mg/30mL; mg/30mL; mg/30mL
Flu and Severe Cold is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by CVS Pharmacy. The primary component is ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; 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: 59779-0926-08Last 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: 59779-0926-08Last 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: 59779-0926-08Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 59779-0926 |
|---|---|
| Product ID | 59779-926_83591a87-bb64-41ea-ab9b-229b1d49fe8d |
| 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 | Flu and Severe Cold |
| Proprietary Name Suffix | Daytime Relief |
| Non-Proprietary Name | ACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCL |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 650; 20; 10 |
| Active Ingredient Units | mg/30mL; mg/30mL; mg/30mL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | CVS Pharmacy |
| 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 | n/a |
Package
Package Images
NDC 59779-0926-08 (59779092608)
| NDC Package Code | 59779-926-08 |
|---|---|
| Billing NDC | 59779092608 |
| Package | 245 mL in 1 BOTTLE, PLASTIC (59779-926-08) |
| Marketing Start Date | 2015-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 867f20cf-a822-490b-9f72-f406052b4085 Details
Active ingredients (in each 30 mL)
Uses
Warnings
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may inclide:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 6 doses (12 tablespoons or 180 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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
- 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.
- with any other product containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
- liver disease
- heart disease
- diabetes
- high blood pressure
- thyroid disease
- trouble urinating due to an enlarged prostate gland
- cough accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- cough comes back or occurs with a fever, rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
- do not take more than directed (see overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL= milliliter
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL every 4 hours
- chlldren under 12 years of age: do not use
Inactive ingredients
Principal Display Panel
Daytime Relief
Flu & Severe Cold
Acetaminophen
Pain reliever, fever reducer
Dextromethorphan HBr
Cough suppressant
Phenylephrine HCl
Nasal decongestant
Relief of:
Nasal congestion; cough; fever; body ache; sore throat; headache
Alcohol Content: 10%
Cherry Flavor
For ages 12 & over
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
Failure to follow the drug facts warnings could result in serious consequences.
*This product is not manufactured or distributed by Novartis Consumer Health, Inc., distributor of Theraflu® Daytime Severe Cold & cough.
INGREDIENTS AND APPEARANCE
| FLU AND SEVERE COLD
DAYTIME RELIEF
acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid |
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| Labeler - CVS Pharmacy (062312574) |