CAREONE SINUS CONGESTION AND PAIN DAYTIME NIGHTTIMEacetaminophen,phenylephrine

Transcription

1 CAREONE SINUS CONGESTION AND PAIN DAYTIME NIGHTTIMEacetaminophen,phenylephrine hcl, chlorpheniramine maleate American Sales Company 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 American Sales Company Sinus Conges tion & Pain DayTime NightTime Drug Facts Active ingredients (in each caplet) Sinus Conges tion & Pain Day Acetaminophen 325 mg Phenylephrine HCl 5 mg Purpos e (Day) Pain reliever/fever reducer Nasal decongestant Uses (Day) for the temporary relief of: headache sinus congestion and pressure nasal congestion minor aches and pains helps decongest sinus openings and passages promotes sinus drainage helps clear nasal passages temporarily reduces fever Active ingredients (in each caplet) Sinus Conges tion & Pain Night Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg Purpos e (Night) Pain reliever/fever reducer Antihistamine Nasal decongestant Us es (Night) for the temporary relief of: headache

2 headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains reduces swelling of nasal passages helps decongest sinus openings and passages temporarily reduces fever Warnings Liver warning: These products contain acetaminophen. 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 these products Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or 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 for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking these products. if you have ever had an allergic reaction to these products or any of their ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis glaucoma Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

3 When using these products do not exceed recommended dosage In addition, when using Sinus Congestion & Pain Night: excitability may occur, especially in children drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breas t-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away ( ). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. Directions do not take more than directed (see overdose warning) do not take the Day and Night caplets at the same time do not take more than a total of 10 caplets in 24 hours DAYTIME adults and children 12 years and over take 2 caplets every 4 hours swallow whole do not crush, chew or dissolve children under 12 years ask a doctor NIGHTTIME adults and children 12 years and over take 2 caplets every 4-6 hours

4 swallow whole do not crush, chew or dissolve children under 12 years ask a doctor Inactive ingredients DAYTIME acesulfame potassium, carnauba wax, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, lecithin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide NIGHTTIME acesulfame potassium, carnauba wax, flavor, iron oxide yellow, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide Ques tions or comments? Principal Dis play Panel ADULTS DAYTIME & NIGHTTIME CONVENIENCE PACK SINUS CONGESTION & PAIN PAIN RELIEVER/FEVER REDUCER NASAL DECONGESTANT ANTIHISTAMINE* SEE NEW WARNINGS Acetaminophen Phenylephrine HCl DAYTIME Nasal Congestion Sinus Headache Sinus Pressure Non Drowsy Actual Size 12 CAPLETS Acetaminophen Phenylephrine HCl Chlorpheniramine Maleate NIGHTTIME *Antihistamine in Nighttime only Nasal Congestion Sinus Pressure Runny Nose Headache Actual Size

5 8 CAPLETS

6 CAREONE SINUS CONGESTION AND PAIN DAYTIME NIGHTTIME acetaminophen,phenylephrine hcl, chlorpheniramine maleate kit Product Information Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC: Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 NDC: in 1 CARTON; Type 0 : No t a Co mbinatio n Pro duct Quantity of Parts Part # Package Quantity Total Product Quantity Pa rt 1 6 BLISTER PACK 12 Pa rt 2 4 BLISTER PACK 8 Part 1 of 2 CAREONE SINUS CONGESTION AND PAIN DAYTIME acetaminophen, phenylephrine hcl tablet Product Information

7 Route of Ad minis tration ORAL Active Ing redient/active Moiety Ing redient Name Basis o f Streng th Streng th ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE - UNII:1WS29 7W6 MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ing redients Ing redient Name ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 ) CARNAUBA WAX (UNII: R12CBM0 EIZ) CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U) PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A) PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) PO VIDO NES (UNII: FZ9 8 9 GH9 4E) STEARIC ACID (UNII: 4ELV7Z6 5AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) CRO SPO VIDO NE (UNII: MK) Streng th Product Characteristics Color GREEN S core no sco re Shape CAPSULE Siz e 16 mm Flavor Imp rint Cod e L272 Contains Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 6 in 1 CARTON 1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part /16 /20 11 Part 2 of 2 CAREONE SINUS CONGESTION AND PAIN NIGHTTIME acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet, film coated

8 Product Information Route of Ad minis tration ORAL Active Ing redient/active Moiety Ing redient Name Basis o f Streng th Streng th ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D) ACETAMINOPHEN 325 mg CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE - UNII:3U6 IO19 6 5U) PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE - UNII:1WS29 7W6 MV) CHLORPHENIRAMINE MALEATE PHENYLEPHRINE HYDROCHLORIDE 2 mg 5 mg Inactive Ing redients Ing redient Name ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 ) CARNAUBA WAX (UNII: R12CBM0 EIZ) CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U) PO LYETHYLENE GLYCO LS (UNII: 3WJQ0 SDW1A) PO LYVINYL ALCO HO L (UNII: 532B59 J9 9 0 ) PO VIDO NES (UNII: FZ9 8 9 GH9 4E) STEARIC ACID (UNII: 4ELV7Z6 5AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIO XIDE (UNII: 15FIX9 V2JP) FERRIC O XIDE YELLO W (UNII: EX438 O2MRT) Streng th Product Characteristics Color WHITE (o ff white) S core 2 pieces Shape CAPSULE Siz e 16 mm Flavor Imp rint Cod e L476 Contains Packag ing # Item Co de Packag e Descriptio n Marketing Start Date Marketing End Date 1 4 in 1 CARTON 1 2 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date OTC mo no graph final part /16 /20 11 Marketing Information Marke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

9 OTC mo no graph final part /16 /20 11 Labeler - American Sales Company ( ) Revised: 11/2015 American Sales Company