NDC | 0363-0602-06 |
Set ID | 3568f379-3743-4a83-b7b1-887c19d24020 |
Category | HUMAN OTC DRUG LABEL |
Packager | Walgreen Co. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
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.
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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.
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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
- INDICATIONS & USAGE
-
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
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
-
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
- INACTIVE INGREDIENT
- 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 solutionProduct 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)