Walgreens Sugar Free Nighttime Wal-Flu Severe Cold and Cough Natural Honey Lemon Flavor: Package Insert and Label Information

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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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.

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

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

– 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 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 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

– 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 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.

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

Keep out of reach of children.

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.

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.

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME
ASPARTAME
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
CITRIC ACID MONOHYDRATE
MALTODEXTRIN
SILICON DIOXIDE
SODIUM CITRATE
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 Multilevel Packaging
1 NDC:0363-0602-06 6 GRANULE, FOR SOLUTION in 1 BOX None
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)

Revised: 12/2015 Walgreen Co.

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