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NDC 63868-0736-24 Cold and Flu 325; 10; 5 mg/1; mg/1; mg/1 Details
Cold and Flu 325; 10; 5 mg/1; mg/1; mg/1
Cold and Flu is a ORAL CAPSULE, LIQUID FILLED in the HUMAN OTC DRUG category. It is labeled and distributed by QUALITY CHOICE (Chain Drug Marketing Association). 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: 63868-0736-24Last 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: 63868-0736-24Last 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: 63868-0736-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63868-0736 |
|---|---|
| Product ID | 63868-736_b5f0e71e-0fd1-47d4-9b02-3623c5f8f86a |
| 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 | Cold and Flu |
| Proprietary Name Suffix | Daytime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | CAPSULE, LIQUID FILLED |
| Route | ORAL |
| Active Ingredient Strength | 325; 10; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | QUALITY CHOICE (Chain Drug Marketing Association) |
| 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 | 2024-12-31 |
Package
Package Images
NDC 63868-0736-24 (63868073624)
| NDC Package Code | 63868-736-24 |
|---|---|
| Billing NDC | 63868073624 |
| Package | 24 BLISTER PACK in 1 CARTON (63868-736-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK |
| Marketing Start Date | 2021-04-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL fc7954a6-d061-4160-b1d1-a19eb9eabff4 Details
Active ingredients (in each softgel)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen I 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday while using this product
Allery 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 the user has
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
Stop use and ask a doctor if
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- nervousness, dizziness, or sleeplessness occur
- 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.
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 4 doses in 24-hour period
- adults and children 12 years and over: take 2 softgels with water every 4 hours
- swallow whole; do not crush, chew, or dissolve
- children under 12 years: do not use
- When using Day Time and Night Time products, carefully read each label to ensure correct dosing
Inactive ingredients
Principal Display Panel
†Compare to the Active Ingredients in VICKS® DAYQUIL® COLD & FLU LIQUICAPS®
Non-Drowsy
Day Time
Multi-Symptom Relief For Cold/Flu
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Pain Reliever | Fever Reducer
Cough Suppressant | Nasal Decongestant
Non-Drowsy | Alcohol Free | Antihistamine Free
Softgels
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OR TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
*This product is not manufactured or distributed by The Procter & Gamble Company. Vicks® DayQuil® and LiquiCaps® are registered trademarks of The Procter & Gamble Company.
Distributed by C.D.M.A., Inc©
43157 W 9 Mile Rd
Novi, MI 48375
INGREDIENTS AND APPEARANCE
| COLD AND FLU
DAYTIME
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled |
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| Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774) |