ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG, GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG- acetaminophen 500mg, dextromethorphan

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)
Available from:
Strive Pharmaceuticals Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
*temporarily relief of occasional heaches and minor aches and pains with accompanying sleeplessness Pain reliever / fever reducer, cough suppressant, expectorant, nasal decongestant
Authorization status:
OTC monograph final
Authorization number:
70692-108-41

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.

----------

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

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

*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:

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

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

store at room temperature between 20

C - 25

C (68

F - 77

avoid excessive heat and humidity

ACETAMINOPHEN 500MG, DEXTROMETHORPHAN HBR 10MG,

GUAIFENESIN 200MG, PHENYLEPHRINE HCL 5MG

acetaminophen 500mg, dextromethorphan hbr 10mg, guaifenesin 200mg, phenylephrine hcl 5mg tablet

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:70 6 9 2-10 8

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE -

UNII:1WS29 7W6 MV)

PHENYLEPHRINE

HYDROCHLORIDE

5 mg

DEXTRO METHO RPHAN HYDRO BRO MIDE (UNII: 9 D2RTI9 KYH)

(DEXTROMETHORPHAN - UNII:7355X3ROTS)

DEXTROMETHORPHAN

HYDROBROMIDE

10 mg

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

GUAIFENESIN (UNII: 49 5W7451VQ) (GUAIFENESIN - UNII:49 5W7451VQ)

GUAIFENESIN

20 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STEARIC ACID (UNII: 4ELV7Z6 5AP)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

DIBASIC CALCIUM PHO SPHATE DIHYDRATE (UNII: O7TSZ9 7GEP)

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

MICA (UNII: V8 A1AW0 8 8 0 )

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

TALC (UNII: 7SEV7J4R1U)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

Product Characteristics

Color

o ra nge

S core

no sco re

S hap e

CAPSULE

S iz e

19 mm

Flavor

Imprint Code

S70 1

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:70 6 9 2-10 8 -41

4 in 1 PACKAGE; Type 0 : No t a Co mbinatio n Pro duct

12/20 /20 18

Marketing Information

Strive Pharmaceuticals Inc

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

12/20 /20 18

Labeler -

Strive Pharmaceuticals Inc (080028013)

Revised: 12/2018

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