NOVEXCOLD- acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution

NovexCold by

Drug Labeling and Warnings

NovexCold by is a Otc medication manufactured, distributed, or labeled by Herbion Pakistan (Pvt.) Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each packet)

Acetaminophen, 650 mg
Pheniramine maleate, 20 mg
Phenylephrine HCl, 10 mg

PURPOSE

Purposes
Pain reliever / fever reducer
Antihistamine
Nasal decongestant

INDICATIONS & USAGE

Uses
temporarily relieves these symptoms due to a cold:
minor aches and pains minor sore throat pain headache nasal and sinus congestion runny nose sneezing itchy nose or throat

itchy, watery eyes due to hay fever

temporarily reduces fever

WARNINGS

Warnings

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

 more than 4,000 mg of acetaminophen in 24 hours  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.

ASK DOCTOR

Ask a doctor before use if you have
liver disease heart disease high blood pressure thyroid disease diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema, or chronic bronchitis a sodium-restricted diet

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers taking the blood thinning drug warfarin

When using this product
do not exceed recommended dosage
avoid alcoholic drinks
may cause drowsiness
alcohol, sedatives, and tranquilizers may increase drowsiness
be careful when driving a motor vehicle or operating machinery
excitability may occur, especially in children

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occurs pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days new symptoms occur redness or swelling is present. These could be signs of a serious condition.

If pregnant or breast-feeding,
ask a health care professional before use.

DO NOT USE

Do not use
in a child under 12 years of age if you are allergic to acetaminophen
with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
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.

DOSAGE & ADMINISTRATION

Directions
do not use more than directed
take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor

• AGE:

  DOSE

• Adults and children 12 years of age and over:

  One packet

• Children under 12 years of age:

  Do not use

dissolve contents of one packet into 8 oz. hot water; sip while hot. Consume entire drink within 10 - 15 minutes.

if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

OTHER SAFETY INFORMATION

Other information

■each packet contains: Sodium 9.37 mg
■ Protect from heat and moisture.
■ Do not use if printed packet is torn or punctured.
■ Store between 68-77°F (20-25°C)

INACTIVE INGREDIENT

Inactive ingredients
Calcium phosphate, Citric acid, Lemon flavour, Malic acid, Sodium citrate, Sucrose, Titanium dioxide

QUESTIONS

Questions?

Call 1-888-(OK-HERBION) 654-3724, Monday through Friday, 9am - 5pm EST

NDC:

44237-044-04 NovexCold Flu & Sore ThroatAcetaminophen- Pain Reliever / Fever Reducer Pheniramine Maleate- Antihistamine Phenylephrine HCl- Nasal Decongestant √Nasal Congestion√Sore Throat√Headache√Body Ache√Runny Nose√Fever 10 Packets  Lemon flavor

INGREDIENTS AND APPEARANCE

NOVEXCOLD 
acetaminophen, pheniramine maleate, phenylephrine hcl powder, for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44237-044
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 22 g
PHENIRAMINE MALEATE (UNII: NYW905655B) (PHENIRAMINE - UNII:134FM9ZZ6M)	PHENIRAMINE MALEATE	20 mg  in 22 g
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	10 mg  in 22 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
CALCIUM PHOSPHATE, UNSPECIFIED FORM (UNII: 97Z1WI3NDX)
MALIC ACID (UNII: 817L1N4CKP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44237-044-04	10 in 1 CARTON	03/25/2020
1		22 g in 1 PACKET; 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	03/25/2020

Labeler - Herbion Pakistan (Pvt.) Ltd (645482936)

Registrant - Herbion Pakistan (Pvt.) Ltd (645482936)

Establishment
Name	Address	ID/FEI	Business Operations
Herbion Pakistan (Pvt.) Ltd		645482936	manufacture(44237-044)