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NDC 76095-0010-20 Cold Medicine 325; 4; 10 mg/1; mg/1; mg/1 Details
Cold Medicine 325; 4; 10 mg/1; mg/1; mg/1
Cold Medicine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by MIDWAY IMPORTING INC.. The primary component is ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; 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: 76095-0010-20Last Updated: 12/01/2022
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: 76095-0010-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Chlorpheniramine
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: 76095-0010-20Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
NDC | 76095-0010 |
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Product ID | 76095-010_eb00f3b1-ba62-57ff-e053-2995a90a4787 |
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 Medicine |
Proprietary Name Suffix | XL3 FORTE |
Non-Proprietary Name | Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET |
Route | ORAL |
Active Ingredient Strength | 325; 4; 10 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
Labeler Name | MIDWAY IMPORTING INC. |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC] |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | M012 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 76095-0010-20 (76095001020)
NDC Package Code | 76095-010-20 |
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Billing NDC | 76095001020 |
Package | 2 BLISTER PACK in 1 BOX (76095-010-20) / 10 TABLET in 1 BLISTER PACK (76095-010-02) |
Marketing Start Date | 2018-02-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 58252f15-485c-3061-e053-2a91aa0a2320 Details
Active ingredients (in each tablet)
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take ■ more than 6 tablets 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
Alergy 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
Do not use
■ If you are allergic to acetaminophen ■ more than 10 days unless directed by a doctor ■ for more than 3 days for fever unless directed by a doctor ■ if you are taking a 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 contasins an MAOI, ask a doctor or pharmacist before taking this product. ■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask adoctor before use if you have
Ask a doctor or pharmacist before use if you
When using this product
Stop use and ask a doctor if
Keep out of reach of children
If pregnant or breast-feeding, ask a health professional before use. 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
Other Information
Inactive Ingredients
Questions and Comments?
INGREDIENTS AND APPEARANCE
COLD MEDICINE
XL3 FORTE
acetaminophen chlorpheniramine maleate phenylepherine hydrochloride tablet |
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Labeler - MIDWAY IMPORTING INC. (611851627) |