NDC | 69365-003-02 |
Set ID | 104a3cba-6eb2-48b3-e054-00144ff8d46c |
Category | HUMAN OTC DRUG LABEL |
Packager | JW HOLDINGS |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART343 |
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Active Ingredients (in each tablet) Purpose
Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
Guaifenesin 35mg…………………………………………………………………………….……...expectorant
Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestantDextromethorphan HBr 8mg…………………………………………………cough suppression
Diphenhydramine HCl 15mg………………………………………………..antihistamine - Inactive Ingredients
- Uses
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Warnings
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets in 24 hours. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product - INDICATIONS & USAGE
- Directions
- Ask a doctor before usei if
- Ask a doctor or pharmacist before use if you
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Do not use
■ For children who are younger than 3 months old. (new born baby)
■ If you ever had an allergic reaction to this product or any of its ingredients.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist) - Keep out of reach of children.
- If pregnant or breast-feeding
- Questions or Comments?
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Stop use and ask a doctor if
■ nervousness, dizziness, or sleeplessness, constipation occurs
■ redness or swelling is present ■ fever get worse or lasts more than 3 days
■ new severe symptoms occur such as shock (anaphylaxis), Stevens Johnson Syndrome, Lyell Syndrome, Asthma, Dyshepatia or Interstitial lung diseases.
■ pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose. - When using this product
- Other Information
- Overdose warning
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PRINCIPAL DISPLAY PANEL
NDC 69365-003-01
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Facol Cold & Flu Night
MULTI
Soft liquid filled capsule
Guaifenesin-Expectorant
Acetaminophen-Fever/pain reliever
Phenylephrine HCl-Nasal Decongestant
Dextromethorphan HBr- Cough Suppressant
Diphenhydramine HCl-Antihistamine
sleep aid
10 capsules
JW Pharmaceuticals
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INGREDIENTS AND APPEARANCE
FACOL COLD AND FLU NIGHT
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69365-003 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 200 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 35 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 8 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 18.75 mg Inactive Ingredients Ingredient Name Strength GARDENIAN BLUE (UNII: 54A6568109) 0.49 mg POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 440.25 mg WATER (UNII: 059QF0KO0R) 70.4 mg PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 40 mg POVIDONE K29/32 (UNII: 390RMW2PEQ) 33 mg GELATIN (UNII: 2G86QN327L) 206.22 mg SORBITOL (UNII: 506T60A25R) 142.88 mg Product Characteristics Color blue (Light bluish liquid filled soft gel) Score no score Shape CAPSULE Size 20mm Flavor Imprint Code FacN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69365-003-02 1 in 1 CARTON 08/01/2015 1 1 in 1 BLISTER PACK 1 10 in 1 CAPSULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 08/01/2015 Labeler - JW HOLDINGS (631094492) Registrant - JW HOLDINGS (631094492) Establishment Name Address ID/FEI Business Operations RP Bio Inc. 689851235 manufacture(69365-003) , pack(69365-003) , analysis(69365-003) , label(69365-003) , sterilize(69365-003)