![WALGREENS WAL-FLU COLD AND SORE THROAT LEMON FLAVOR (ACETAMINOPHEN, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL) GRANULE, FOR SOLUTION [WALGREEN CO.]](https://medic.hrt.org//dailymed/images/fc99da1f-5ce7-4bc4-b6b5-09020cbdac64/carton.jpg)
| NDC | 0363-0601-06 |
| Set ID | fc99da1f-5ce7-4bc4-b6b5-09020cbdac64 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Walgreen Co. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- ACTIVE INGREDIENT
-
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.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 physician promptly.
Do not use:
- In a child under 4 years of age.
- If you are allergic to acetaminophen.
- with any other drug containing acetaminophen (prescription and 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.Ask a doctor before use if you have
- liver disease - heart disease - high blood pressure - thyroid disease - diabetes - glaucoma - trouble urinating due to an enlarged prostate gland - cough that occurs with too much phlegm (mucus) - cough that lasts or is chronic such as occurs with smoking, asthma or emphysema- 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. -
DOSAGE & ADMINISTRATION
Directions
- do not use more than directed
- take every 4 hours; not to exceed 6 packets in 24 hours or as directed by a doctorAge Dose children under 4 years of age do not use children 4 to under 12 years of age do not use unless directed by a doctor adults and children 12 years of age and over one packet - dissolve contents of one packet in 8 oz. hot water; sip while hot. Consume entire drink within 10-15 minutes.
- 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
WALGREENS WAL-FLU COLD AND SORE THROAT LEMON FLAVOR
acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0601 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:0363-0601-06 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 10/07/2013 Labeler - Walgreen Co. (008965063)
