ONLY FOR COLD AND FLU COUGH SUPPRESSANT- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Only For by

Drug Labeling and Warnings

Only For by is a Otc medication manufactured, distributed, or labeled by O4 Global Trading Usa, Llc . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active ingredient (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant

Uses:

temporarily relieves:
     minor aches & pains associated with a cold, the flu or a sore throat headache cough due to minor throat & bronchial irritation nasal congestion sinus congestion & pressure
temporarily reduces fever reduces swelling in nasal passages
promotes nasal and/or sinus drainage temporarily restores free breathing through the nose
Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus, and make coughs more productive

Warnings:

Liver warning:
This product contains acetaminophen.
Severe liver damage may occur if you take: with other drugs containing acetaminophen
more than 8 caplets in 24 hrs, which is the maximum daily amount for this product
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 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 this product.
for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.
if you have ever had an allergic reaction to this product or any of its ingredients

Do not use, ask a doctor if you have
liver disease heart disease high blood pressure thyroid disease diabetes
trouble urinating due to an enlarged prostate gland cough that occurs with too much phlegm (mucus) persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or a pharmacist before use if you
taking the blood thinning drug warfarinis.

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: Taking more than directed can cause serious health problems. In case of 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.

Directions:

• Do not take more than directed - See Overdose warning
• take with a full glass of water do not exceed 8 caplets per 24 hours

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

when using other Daytime or Night time products, carefully read each label to ensure correct dosing

Other Information:

Store at room temperature between 20-25°C (68-77°F). Avoid excessive heat and humidity

Inactive Ingredients:

colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow #6, gelatin, magnesium stearate, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, polyvinyl povidone, purified water, sodium starch glycolate, starch, stearic acid, talc.

Questions Or Comments ?

1-833-665-9444.

SPL UNCLASSIFIED SECTION

NDC: 73006-108-41

READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION.

Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.

www.onlyfor.com

Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Tear along perforation push product through foil

Packaging

INGREDIENTS AND APPEARANCE

ONLY FOR   COLD AND FLU COUGH SUPPRESSANT
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73006-108
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICA (UNII: V8A1AW0880)
MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL (94000 MW) (UNII: C1MS7RRZ6L)
POVIDONE K15 (UNII: E54VE15114)
WATER (UNII: 059QF0KO0R)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL (CAPLET)	Size	19mm
Flavor		Imprint Code	S701
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73006-108-41	1 in 1 CARTON	02/01/2019
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	02/01/2019

Labeler - O4 Global Trading Usa, Llc (081226861)