Label: FACOL COLD AND FLU NIGHT- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 69365-003-01 - Packager: JW HOLDINGS
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated November 29, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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:69365-003-01 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)