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NDC 00904-6760-24 acetaminophen congestion and pain 325; 5 mg/1; mg/1 Details
acetaminophen congestion and pain 325; 5 mg/1; mg/1
acetaminophen congestion and pain is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is ACETAMINOPHEN; 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: 00904-6760-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
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: 00904-6760-24Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 00904-6760 |
|---|---|
| Product ID | 0904-6760_c90f3d54-12b7-4bab-8af9-05e848414633 |
| Associated GPIs | 43991002100317 |
| GCN Sequence Number | 059707 |
| GCN Sequence Number Description | phenylephrine HCl/acetaminophn TABLET 5 MG-325MG ORAL |
| HIC3 | B4T |
| HIC3 Description | DECONGEST-ANALGESIC,NON-SALICYLATE COMB. |
| GCN | 25468 |
| HICL Sequence Number | 000436 |
| HICL Sequence Number Description | PHENYLEPHRINE HCL/ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | acetaminophen congestion and pain |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen, Phenylephrine HCl |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | Adrenergic alpha1-Agonists [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 00904-6760-24 (00904676024)
| NDC Package Code | 0904-6760-24 |
|---|---|
| Billing NDC | 00904676024 |
| Package | 12 BLISTER PACK in 1 CARTON (0904-6760-24) / 2 TABLET, FILM COATED in 1 BLISTER PACK |
| Marketing Start Date | 2007-01-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 29bd1c43-fe8d-45d1-ac7b-b8d991f47f38 Details
Uses
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- temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold:
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- headache
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- sinus congestion and pressure
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- nasal congestion
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- minor aches and pains
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- helps decongest sinus openings and passages
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- promotes sinus drainage
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- helps clear nasal passages
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- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
- •
- blisters
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- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
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- 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
Directions
Inactive ingredients
Principal Display Panel
Compare to the active ingredients in Tylenol® SINUS + HEADACHE
Acetaminophen
CONGESTION AND PAIN
CAPLETS
Acetaminophen – Pain reliever / Fever reducer
Phenylephrine HCl – Nasal decongestant
Relieves: Sinus Headache, Sinus Pressure & Nasal Congestion
Actual Size
For Adults
24 CAPLETS
with cool Blast Flavor
NON-DROWSY
DAYTIME
INGREDIENTS AND APPEARANCE
| ACETAMINOPHEN CONGESTION AND PAIN
acetaminophen, phenylephrine hcl tablet, film coated |
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| Labeler - Major Pharmaceuticals (191427277) |