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NDC 49035-0560-08 Cold Multi-Symptom 325; 10; 5 mg/1; mg/1; mg/1 Details
Cold Multi-Symptom 325; 10; 5 mg/1; mg/1; mg/1
Cold Multi-Symptom is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Wal-Mart Stores 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: 49035-0560-08Last 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: 49035-0560-08Last 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: 49035-0560-08Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 49035-0560 |
|---|---|
| Product ID | 49035-560_0cccc601-0ef0-45d5-b138-e48e5de99380 |
| Associated GPIs | 43996903400320 |
| GCN Sequence Number | 060981 |
| GCN Sequence Number Description | d-methorphan/PE/acetaminophen TABLET 10-5-325MG ORAL |
| HIC3 | B4M |
| HIC3 Description | NON-OPIOID ANTITUSSIVE-DECONGESTANT-ANALGESIC COMB |
| GCN | 27135 |
| HICL Sequence Number | 008885 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Cold Multi-Symptom |
| Proprietary Name Suffix | Daytime |
| Non-Proprietary Name | Acetaminophen, Dextromethorphan HBr, and Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| 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 | Wal-Mart Stores 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 49035-0560-08 (49035056008)
| NDC Package Code | 49035-560-08 |
|---|---|
| Billing NDC | 49035056008 |
| Package | 2 BLISTER PACK in 1 CARTON (49035-560-08) / 12 TABLET in 1 BLISTER PACK |
| Marketing Start Date | 2008-03-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9ecafbb2-00b3-4abb-aecf-9595f680ff46 Details
Active ingredients (in each gelcap)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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
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
- 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
- diabetes
- heart disease
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- high blood pressure
- thyroid disease
- difficulty in urination due to enlargement of the prostate gland
- 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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache
These could be signs of a serious condition.
Directions
Other information
Inactive ingredients
croscarmellose sodium, crospovidone, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, silica gel, stearic acid, titanium dioxide
Principal Display Panel
NDC 49035-560-08
equate™
Compare to Tylenol® COLD MAX Day Active Ingredients*
Rapid Release
Cold
Multi-Symptom
Acetaminophen, Dextromethorphan HBr,
Phenylephrine HCl
Pain Reliever, Fever Reducer,
Cough Suppressant, Nasal Decongestant
Daytime Non-Drowsy
• Headache, fever, sore throat
• Nasal congestion
• Cough
24
GELCAPS
Actual Size
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Satisfaction guaranteed-Or we'll replace it or give you your money back. For questions or comments, please call 1-888-287-1915.
DISTRIBUTED BY: Wal-Mart Stores, Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol® COLD MAX Day.
50844 REV0216A56008
Equate 44-560
INGREDIENTS AND APPEARANCE
| COLD MULTI-SYMPTOM
DAYTIME
acetaminophen, dextromethorphan hbr, and phenylephrine hcl tablet |
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| Labeler - Wal-Mart Stores Inc (051957769) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | MANUFACTURE(49035-560) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | PACK(49035-560) | |