WALGREENS WAL-FLU COLD AND SORE THROAT LEMON FLAVOR- acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solution

Walgreens Wal-Flu Cold and Sore Throat by

Drug Labeling and Warnings

Walgreens Wal-Flu Cold and Sore Throat by is a Otc medication manufactured, distributed, or labeled by Walgreen Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each packet)                        Purpose

Acetaminophen 325 mg...................................Pain reliever/Fever reducer

Pheniramine maleate 20 mg................................................Antihistamine

Phenylephrine hydrochloride 10 mg.............................Nasal decongestant.

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.

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

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

Overdose Warning:

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.

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 doctor

• Age: 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

Other Information

- each packet contains: sodium 66 mg
- store at controlled room temperature 20-25C (68-77F). Protect from heat and moisture.

INACTIVE INGREDIENT

Citric acid, D and C Yellow 10, Ethylcellulose, FD and C Red 40, Flavor, Microcrystalline cellulose, Povidone, Silicon dioxide, Sodium citrate, Starch, Sugar and Vitamin C.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS WAL-FLU COLD AND SORE THROAT  LEMON FLAVOR
acetaminophen, pheniramine maleate, phenylephrine hcl granule, for solution

Product 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)