ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG- acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mg tablet 
Strive Pharmaceuticals Inc

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.

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Cold & Flu - Gripa (Acetaminophen 325mg; Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg)

Acetaminophen 325mg; Dextromethorphan HBr 10mg; Gauifenesin 200mg; Phenylephrine HCl 5mg

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow#6, magnesium staerate, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, stearic acid, talc

adults & children 12 years of age & over2 caplets with water every 4 hours
children 4 to 12 years of ageask a doctor
children under 4 years of agedo not use

*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

if a skin reaction occurs, stop use and seek medical help right away

Sore throat warning:

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly

Do not use

Ask a doctor before use if you have

Ask a doctor or a pharmacist before use if you are

When using this product

Stop use and ask a doctor if

These could be signs of a serious condition

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

Overdose warning: 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.

Keep out of reach of children

Overdose Warning: 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.

Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant

CT10841

ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG 
acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mg tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70692-108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MICA (UNII: V8A1AW0880)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TALC (UNII: 7SEV7J4R1U)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
ColororangeScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code S701
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70692-108-414 in 1 PACKAGE; Type 0: Not a Combination Product12/20/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/20/2018
Labeler - Strive Pharmaceuticals Inc (080028013)

Revised: 11/2020
Document Id: b43d2d83-1d7c-6187-e053-2a95a90a7bc2
Set id: 9239bf18-0e2b-20d5-e053-2a95a90addc8
Version: 2
Effective Time: 20201116
 
Strive Pharmaceuticals Inc