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NDC 63868-0578-24 Allergy Multisymptom 325; 2; 5 mg/1; mg/1; mg/1 Details
Allergy Multisymptom 325; 2; 5 mg/1; mg/1; mg/1
Allergy Multisymptom is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by CHAIN DRUG MARKETING ASSOCIATION 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: 63868-0578-24Last 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: 63868-0578-24Last 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: 63868-0578-24Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Phenylephrine
Product Information
| NDC | 63868-0578 |
|---|---|
| Product ID | 63868-578_bccb3894-65e3-0c3d-e053-2a95a90a8d82 |
| 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 | Allergy Multisymptom |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, and PHENYLEPHRINE HYDROCHLORIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 325; 2; 5 |
| Active Ingredient Units | mg/1; mg/1; mg/1 |
| Substance Name | ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE |
| Labeler Name | CHAIN DRUG MARKETING ASSOCIATION 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 | part341 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63868-0578-24 (63868057824)
| NDC Package Code | 63868-578-24 |
|---|---|
| Billing NDC | 63868057824 |
| Package | 2 BLISTER PACK in 1 CARTON (63868-578-24) / 12 TABLET, COATED in 1 BLISTER PACK |
| Marketing Start Date | 2020-06-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5 Details
SPL UNCLASSIFIED SECTION
Uses
- temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- temporarily relieves these additional symptoms of hay fever:
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- 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.
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
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Directions
- do not take more than directed (see overdose warning)
| adults and children 12 years and over |
|
| children under
12 years |
|
Other information
Inactive ingredients
acesulfame potassium, colloidal silicon dioxide, corn starch, croscarmellose sodium, crospovidone, flavor, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
PRINCIPAL DISPLAY PANEL
QUALITY CHOICE®
NDC 63868-578-24
Allergy Multi-Symptom
Pain Reliever, Nasal Decongestant, Antihistamine
Acetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate
For Relief of:
Headache
Sinus Pressure | Nasal Congestion
Runny Nose | Sneezing
Itchy, Watery Eyes
May Cause Drowsiness
24 COOL TASTE CAPLETS
Actual Size
INGREDIENTS AND APPEARANCE
| ALLERGY MULTISYMPTOM
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated |
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| Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774) |