WALGREENS SUGAR FREE NIGHTTIME WAL-FLU SEVERE COLD AND COUGH NATURAL HONEY LEMON FLAVOR- acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution

Walgreens Sugar Free Nighttime Wal-Flu severe cold and cough by

Drug Labeling and Warnings

Walgreens Sugar Free Nighttime Wal-Flu severe cold and cough 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 650 mg .......................................Pain reliever/Fever reducer

Diphenhydramine hydrochloride 25 mg ........Antihistamine/Cough suppressant

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

PURPOSE

Uses

- temporarily relieves:

- minor aches and pains - minor sore throat pain

- headache - nasal and sinus congestion

- runny nose - sneezing

- itchy nose and throat - itchy, watery eyes due to hay fever

- cough due to minor throat and bronchial irritation

- temporarily reduces fever.

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.

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 doctor promptly.

DO NOT USE

Do not use

- In a child under 4 years of age.

- With any other drug containing acetaminophen (prescription and nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.

- with any other product containing diphenhydramine, even one used on the skin

-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 a MAOI, ask a doctor or pharmacist before taking this product.

ASK DOCTOR

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

- a breathing problem such as emphysema, asthma, or chronic bronchitis

- cough that occurs with too much phlegm (mucus)

- cough that lasts or is chronic such as occurs with smoking, asthma or emphysema.

ASK DOCTOR/PHARMACIST

Ask a doctor or pharmacist before use if you are

- taking sedatives or tranquilizers

- taking the blood thinning drug warfarin.

INDICATIONS & USAGE

When using this product

- do not exceed recommended dosage

- avoid alcoholic drinks - marked drowsiness may occur

- 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

Stop use and ask a doctor if

- nervousness, dizziness, or sleeplessness occurs

- fever gets worse or lasts more than 3 days - redness or swelling is present

- new symptoms occur - symptoms do not get better or worsen

- pain, cough or nasal congestion gets worse or lasts more than 7 days

- cough comes back or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

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.

- adults and children 12 years of age and over: dissolve contents of one packet into 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

Other information

- each packet contains: potassium 10 mg,

sodium 19 mg

- phenylketonurics: contains phenylalanine

11 mg per packet

- store at controlled room temperature

20-25C (68-77F). Protect from

excessive heat and moisture.

INACTIVE INGREDIENT

Acesulfame K, aspartame, calcium phosphate dibasic, citric acid, D and C Yellow 10, maltodextrin, natural flavor, silicon dioxide, sodium citrate dihydrate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

WALGREENS SUGAR FREE NIGHTTIME WAL-FLU SEVERE COLD AND COUGH  NATURAL HONEY LEMON FLAVOR
acetaminophen, diphenhydramine hcl, and phenylephrine hcl. granule, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-0602
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ACESULFAME (UNII: MA3UYZ6K1H)
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Product Characteristics
Color	yellow (D & C Yellow 10)	Score
Shape		Size
Flavor	HONEY (Natural Honey & Lemon Flavor) , LEMON (Natural Honey & Lemon Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0602-06	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	09/15/2014

Labeler - Walgreen Co. (008965063)