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NDC 50804-0316-08 Severe Cold and Cough Relief 650; 20; 10 mg/30mL; mg/30mL; mg/30mL Details
Severe Cold and Cough Relief 650; 20; 10 mg/30mL; mg/30mL; mg/30mL
Severe Cold and Cough Relief is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Good Sense (Geiss, Destin & Dunn, Inc.). 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: 50804-0316-08Last Updated: 11/30/2022
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: 50804-0316-08Last Updated: 11/30/2022
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: 50804-0316-08Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50804-0316 |
|---|---|
| Product ID | 50804-316_3f972a81-2984-49f6-b3a5-488944034142 |
| Associated GPIs | 43996903400910 |
| 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 and Cough Relief |
| Proprietary Name Suffix | Daytime |
| 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 | Good Sense (Geiss, Destin & Dunn, 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 | n/a |
Package
Package Images
NDC 50804-0316-08 (50804031608)
| NDC Package Code | 50804-316-08 |
|---|---|
| Billing NDC | 50804031608 |
| Package | 245 mL in 1 BOTTLE, PLASTIC (50804-316-08) |
| Marketing Start Date | 2016-07-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL d0b0c0a2-97f5-4967-87e4-df0f8be6bd0b Details
Active ingredients (in each 30 mL)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- 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
- 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 drug 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
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with a 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) right away. 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 (180 mL) 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
Other information
Inactive ingredients
Principal Display Panel
For Ages 12 Years and Over
Adult
DayTime
Severe Cold & Cough Relief
Acetaminophen - Pain reliever/Fever reducer
Dextromethorphan HBr - Cough Suppressant
Phenylephrine HCl - Nasal Decongestant
- Nasal Congestion
- Sore Throat
- Headache
- Body Ache
- Cough
- Fever
Compare to the active ingredients in Theraflu® DayTime Severe Cold & Cough*
Alcohol Content: 10%
Cherry Flavor
FL OZ (mL)
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING.
*This product is not manufactured or distributed by GSK Consumer Health, distributor of Theraflu® Daytime Severe Cold & Cough.
Distributed by: Geiss, Destin & Dunn, Inc.
Peachtree City, GA 30269
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
INGREDIENTS AND APPEARANCE
| SEVERE COLD AND COUGH RELIEF
DAYTIME
acetaminohpen, dextromethorphan hbr, phenylephrine hcl liquid |
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| Labeler - Good Sense (Geiss, Destin & Dunn, Inc.) (076059836) |