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NDC 50804-0805-03 Cold and Head Congestion Severe 325; 200; 5 mg/1; mg/1; mg/1 Details
Cold and Head Congestion Severe 325; 200; 5 mg/1; mg/1; mg/1
Cold and Head Congestion Severe is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by GoodSense. The primary component is ACETAMINOPHEN; 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: 50804-0805-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 50804-0805-03Last Updated: 11/30/2022
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: 50804-0805-03Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 50804-0805 |
|---|---|
| Product ID | 50804-805_ee293ea9-2264-13c9-e053-2995a90aaa07 |
| Associated GPIs | 43996703500310 |
| GCN Sequence Number | 060554 |
| GCN Sequence Number Description | guaifen/phenyleph/acetaminophn TABLET 200-5-325 ORAL |
| HIC3 | B3N |
| HIC3 Description | DECONGESTANT-ANALGESIC-EXPECTORANT COMBINATION |
| GCN | 26743 |
| HICL Sequence Number | 023719 |
| HICL Sequence Number Description | GUAIFENESIN/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Cold and Head Congestion Severe |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 200; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | GoodSense |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 50804-0805-03 (50804080503)
| NDC Package Code | 50804-805-03 |
|---|---|
| Billing NDC | 50804080503 |
| Package | 2 BLISTER PACK in 1 CARTON (50804-805-03) / 12 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2016-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 747512a2-3b6d-496b-ab80-819060314163 Details
SPL UNCLASSIFIED SECTION
Uses
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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, perists 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.
- 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
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough 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 rash or headache that lasts
These could be signs of a serious condition.
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under 12 years |
|
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL
GoodSense®
NDC 50804-805-03
For Adults
Cold + Head Congestion Severe
Acetaminophen, Phenylephrine HCl, Guaifenesin
Pain Reliever/ Fever Reducer, Nasal Decongestant, Expectorant
• Headache + Body Aches
• Fever + Sore Throat
• Nasal Congestion
• Mucus + Chest Congestion
Cool Taste Instant Cooling Sensation
Actual Size
Compare to active ingredients of Tylenol® Cold + Head Congestion Severe†
24 CAPLETS
INGREDIENTS AND APPEARANCE
| COLD AND HEAD CONGESTION SEVERE
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet, coated |
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| Labeler - GoodSense (076059836) |