Label: FACOL COLD AND FLU DAY- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled
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Contains inactivated NDC Code(s)
NDC Code(s): 69365-001-01 - 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(in each tablet) Purpose
- 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
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Directions
■ Do not take more than directed (see overdose warning)
■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day
■ swallow whole-do not crush, chew or dissolve
■ do not take night time capsule in less than 6 hours after taking day time capsule
■ children under 15 years: do not use and ask a doctor. - Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
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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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PRINCILA DISPLAY PANEL
NDC 69365-001-01
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Facol® Cold and Flu Day
MULTI
Soft liquid-filled capsule
Guaifenesin-Expectorant
Acetaminophen-Fever/Pain Reducer
Phenylephrine HCl-Nasal Decongestant
Dextromethorphan HBr-Cough Suppressant
10 capsules
JW pharmaceuticals
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INGREDIENTS AND APPEARANCE
FACOL COLD AND FLU DAY
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69365-001 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 8 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 40 mg POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 459 mg PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 40 mg GELATIN (UNII: 2G86QN327L) 203.93 mg POVIDONE K29/32 (UNII: 390RMW2PEQ) 33 mg SORBITOL (UNII: 506T60A25R) 141.1 mg COCHINEAL (UNII: TZ8Z31B35M) 2.185 mg ALUMINUM OXIDE (UNII: LMI26O6933) 2.185 mg Product Characteristics Color yellow Score no score Shape CAPSULE Size 20mm Flavor Imprint Code FacD Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69365-001-01 1 in 1 KIT 08/01/2015 1 1 in 1 BLISTER PACK; 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(69365-001) , pack(69365-001) , analysis(69365-001) , label(69365-001) , sterilize(69365-001)