ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL tablet

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl by

Drug Labeling and Warnings

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl by is a Otc medication manufactured, distributed, or labeled by OPMX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Acetaminophen 500mg

Chlorpheniramine Maleate 4mg

Phenylephrine HCl 10mg

Purpose

• Active Ingredients (in each caplet): Purpose
• Acetaminophen 500 mg: Pain reliever
• Chlorpheniramine Maleate 4 mg: Antihistamine
• Phenylephrine HCl 10 mg: Nasal descongestant

Uses

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

• Headache
• Nasal congestion
• Sinus congestion & pressure
• Runny nose and sneezing
• Minor aches & pain

Temporarily relieves these additional symptoms of hay fever:

• itching of the nose or throat
• itchy, watery eyes
• helps clear nasal passages
• helps decongest sinus opening and passages

Warnings

Liver warning:

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

• more than 6 tablets in 24 hours, which is the maximum daily amount for this product
• with other drugs contains 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 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.
• if you have ever had an allergic reaction to this product or any of its ingredients
• to make a child sleepy

Ask a doctor before use if you have

• liver disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are:

• taking the blood thinning drug warfarin.
• taking sedatives or tranquilizers

When using this product:

• do not use more than directed
• excitability may occur, especially in children
• drowsiness may occur
• alcohol, sedatives and tranquilizers may increase drowsiness
• avoid drinks
• be careful when driving a motor vehicle or operating machinery

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
• fever gets worse or last more than 3 days
• redness or swelling is present
• new symptoms occur

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
• Swallow whole; do not crush, chew or dissolve
• Do not exceed 6 tablets per 24 hours

• Adults and children 12 years of age & over: 1 tablet with water every 4-6 hours as needed
• Children 4 to 12 years of age: Ask a doctor
• Children under 4 years of age: Do not use

Other information

• Store at room temperature between 20-25°C (68-77ºF)
• Avoid excessive heat and humidity
• Tamper Evident: do not use if package or blister unit is open or shows any sing of tampering

Inactive ingredients

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-222
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (BICONVEX)	Size	13mm
Flavor		Imprint Code	S78
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-222-27	2 in 1 POUCH; Type 0: Not a Combination Product	08/26/2019
2	NDC: 69729-222-37	12 in 1 POUCH; Type 0: Not a Combination Product	08/26/2019
3	NDC: 69729-222-38	144 in 1 POUCH; Type 0: Not a Combination Product	08/26/2019
4	NDC: 69729-222-06	3 in 1 CARTON	09/04/2023
4		2 in 1 POUCH; 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	08/26/2019

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
MEDGEL PRIVATE LIMITED		677385498	manufacture(69729-222)