Label: MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME NIGHTTIME- acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 70692-103-12 - Packager: Strive Pharmaceuticals Inc.
- Category: HUMAN OTC DRUG LABEL
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 16, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients (in each caplet) (Daytime) Purpose Acetaminophen 325mg Pain Reliever Guaifenesin 200mg Expectorant Phenylephrine HCl 5mg Nasal Decongestant Active ingredients (in each caplet) (Nighttime) Purpose Acetaminophen 325mg Pain Reliever Diphenhydramine 12.5mg Anthistamine/Cough suppressant Phenylephrine HCl 5mg Nasal Decongestant - PURPOSE
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INDICATIONS & USAGE
* temporarily relieves:
- nasal congestion
- headache
- minor aches and pain
- sinus congestion and pressure
- runny nose and sneezing (Nighttime only)
- cough (Nighttime only)
* temporarily promotes nasal and/or sinus drainag
* helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
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WARNINGS
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take:
*more than 12 caplets in 24 hrs, which is the maximum daily amount
* with other drugs containing acetaminophen
*3 or more alcoholic drinks every day while using this product
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 have ever had an allergic reaction to this product or any of its ingredients
* with any other drug containing diphenhydramine, even one used on the skin (Nighttime only)
* 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 this product.Ask a doctor before use if you have
* liver disease
* heart disease
* diabetes
* high blood pressure
* thyroid disease
* trouble urinating due to an enlarged prostate gland
* glaucoma (Nighttime only)
* a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
* persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
* cough that occurs with too much phlegm (mucus)Ask a doctor or a pharmacist before use if you are
* taking the blood thinning drug warfarin
* taking sedatives or tranquilizers (Nighttime only)
When using this product
* do not exceed recommended dose
* excitability may occur, especially in children (Nighttime only)
* marked drowsiness may occur (Nighttime only)
* alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
* be careful when driving a motor vehicle or operating machinery (Nighttime only)
* avoid alcoholic beverages (Nighttime only)Stop use and ask a doctor if
* nervousness, dizziness, or sleeplessness occur
* pain, nasal congestion, or cough gets worse or lasts more than 7 days
* new symptoms occur
* fever gets worse or lasts more than 3 days
* redness or swelling is present
* cough comes back or occurs with rash or headache that lasts
These could be signs of a serious conditionIf pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If taking Nighttime and Daytime products,
carefully read each section to ensure correct dosing
Do not take DAYTIME and NIGHTTIME at the same time - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive ingredients (Daytime)
microcrystalline cellulose, dibasic calcium phosphate, croscarmellose sodium, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glycol, titanium dioxide,FD&C yellow #6, FD&C red #40, gelatin, starch, polyvinyl povidone, maltodextrin, sodium starch glycolate
Inactive ingredients (Nightime)
microcrystalline cellulose, dibasic calcium phosphate, corn starch, croscarmellose sodium, talc, colloidal silicon dioxide, stearic acid, magnesium stearate, polyvinyl alcohol, polyethylene glyocol, mica, titanium dioxide, FD&C blue #1, methacrylic acid copolymer, FD&C blue #2, sodium bicarbonate, starch, gelatin, sodium starch glycolate - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME NIGHTTIME
acetaminophen, diphenhydramine hcl, guaifenesin, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-103 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-103-12 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 03/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 8 Part 2 1 BLISTER PACK 4 Part 1 of 2 MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION DAYTIME
acetaminophen, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) TALC (UNII: 7SEV7J4R1U) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) GELATIN (UNII: 2G86QN327L) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MALTODEXTRIN (UNII: 7CVR7L4A2D) MAGNESIUM STEARATE (UNII: 70097M6I30) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C RED NO. 40 (UNII: WZB9127XOA) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange (Reddish Orange) Score no score Shape OVAL Size 19mm Flavor Imprint Code S703 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 final part341 03/01/2018 Part 2 of 2 MULTI SYMPTOM SINUS RELIEF PAIN AND CONGESTION NIGHTTIME
acetaminophen, diphenhydramine hydrochloride, phenylephrine hydrochloride tablet, film coatedProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) TALC (UNII: 7SEV7J4R1U) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STARCH, WHEAT (UNII: 79QS2MG2LP) STEARIC ACID (UNII: 4ELV7Z65AP) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) MICA (UNII: V8A1AW0880) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13) SODIUM BICARBONATE (UNII: 8MDF5V39QO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) STARCH, CORN (UNII: O8232NY3SJ) GELATIN (UNII: 2G86QN327L) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color blue Score no score Shape OVAL Size 19mm Flavor Imprint Code S704 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 4 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 final part341 03/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)