ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG tablet

Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg by

Drug Labeling and Warnings

Acetaminophen 500mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

• take with a full glass of water
• do not take more than directed
• do not exceed 8 caplets per 24 hours

• adults & children 12 years of age & over: 2 caplets with water every 4 hours
• children 4 to 12 years of age: ask a doctor
• children under 4 years of age: do not use

INDICATIONS & USAGE

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

WARNINGS

Liver warning:

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

• more than 8 caplets in 24 hours, which is the maximum daily amount for this product
• 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

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

• with any other drug containing acetaminophen (prescription or non prescription). 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 ths product
• if you have ever had an allergic reaction to this product or any of its 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 prostrate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthama, chronic bronchitis, or emphysema

Ask a doctor or a pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• do not use more than directed

Stop use and ask a doctor if

• you get nervous, dizzy or sleepless
• pain, nasal congestion, or cough 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
• cough comes back or occurs with rash or headache that lasts

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

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.

PURPOSE

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

OTHER SAFETY INFORMATION

• store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
• avoid excessive heat and humidity

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-108
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
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	orange	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	S701
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-108-41	4 in 1 PACKAGE; Type 0: Not a Combination Product	12/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/20/2018

Labeler - Strive Pharmaceuticals Inc (080028013)