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NDC 37000-0450-12 Vicks 650; 4; 30 mg/15mL; mg/15mL; mg/15mL Details
Vicks 650; 4; 30 mg/15mL; mg/15mL; mg/15mL
Vicks is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Procter & Gamble Manufacturing Company. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE.
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: 37000-0450-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Chlorpheniramine relieves red, itchy, watery eyes; sneezing; itchy nose or throat; and runny nose caused by allergies, hay fever, and the common cold. Chlorpheniramine helps control the symptoms of cold or allergies but will not treat the cause of the symptoms or speed recovery. Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Related Packages: 37000-0450-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 37000-0450-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Dextromethorphan
Product Information
| NDC | 37000-0450 |
|---|---|
| Product ID | 37000-450_eac47f30-c6a9-583d-e053-2a95a90accb8 |
| 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 | Vicks |
| Proprietary Name Suffix | Formula 44 Nighttime Cough and Cold |
| Non-Proprietary Name | Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 650; 4; 30 |
| Active Ingredient Units | mg/15mL; mg/15mL; mg/15mL |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE |
| Labeler Name | Procter & Gamble Manufacturing Company |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | M012 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 37000-0450-12 (37000045012)
| NDC Package Code | 37000-450-12 |
|---|---|
| Billing NDC | 37000045012 |
| Package | 354 mL in 1 BOTTLE, PLASTIC (37000-450-12) |
| Marketing Start Date | 2017-07-11 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 4e3f862b-4c1c-21dd-e054-00144ff88e88 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 doses in 24 hours, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily 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 is 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.
Ask a doctor before use if you have
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
SPL UNCLASSIFIED SECTION
Directions
Other information
Inactive ingredients
PRINCIPAL DISPLAY PANEL - 354 ml Bottle Label
INGREDIENTS AND APPEARANCE
| VICKS
FORMULA 44 NIGHTTIME COUGH AND COLD
acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide liquid |
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| Labeler - Procter & Gamble Manufacturing Company (004238200) |