![QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]](https://medic.hrt.org//dailymed/images/7047e4b8-d111-4540-89e0-5f29dc17a03d/carton1.jpg)
| NDC | 63868-765-06 |
| Set ID | 7047e4b8-d111-4540-89e0-5f29dc17a03d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Chain Drug Marketing Association |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Quality Choice Cold and Sore Throat Lemon Flavor
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PURPOSE
Uses
- temporarily relieves these symptoms due to a cold:
- minor aches and pains - headache - minor sore throat pain
- nasal congestion - temporarily reduces fever
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose - sneezing - itchy nose and throat - itchy, watery eyes. -
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take - more than 6 packets 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.
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.Do not use - with any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 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 product containing acetaminophen (see Overdose Warning).Ask a doctor before use if you have
- liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - a breathing problem such as emphysema, asthma, or chronic bronchitis - trouble urinating due to an enlarged prostate gland - a sodium-restricted diet.Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers - the blood thinning drug warfarin.When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks - may cause drowsiness
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children.Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting. These could be signs of a serious condition.Overdose Warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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DOSAGE & ADMINISTRATION
Directions
- do not use more than directed (see Overdose Warning)
- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctor
- adults and children 12 years of age and over: dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- children under 12 years of age: consult a doctor
- If using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat. - INFORMATION FOR PATIENTS
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
QUALITY CHOICE COLD AND SORE THROAT LEMON FLAVOR
acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-765 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M) PHENIRAMINE MALEATE 20 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) ETHYLCELLULOSE (100 MPA.S) (UNII: 47MLB0F1MV) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) ASCORBIC ACID (UNII: PQ6CK8PD0R) Product Characteristics Color yellow (D and C Yellow 10) , red (FD and C Red 40) Score Shape Size Flavor LEMON (Nature Lemon Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-765-06 6 in 1 BOX; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/25/2013 Labeler - Chain Drug Marketing Association (011920774)
