PANCOLD A- acetaminophen, guaifenesin, pentoxyverine citrate, phenylpehrine hydcrochloride, chlorpheniramine maleate, caffeine anhydrous liquid

PANCOLD A by

Drug Labeling and Warnings

PANCOLD A by is a Otc medication manufactured, distributed, or labeled by DONGWHA PHARM. CO. LTD., DONGWHA PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active ingredients (in each 30 mL bottle)

• Acetaminophen 300 mg
• Guaifenesin 80 mg
• Pentoxyverine citrate 15 mg
• Phenylephrine Hydrochloride 10 mg
• Chlorpheniramine maleate 2.5 mg
• Caffeine 30 mg

PURPOSE

Pain Reliever-Fever Reducer, Expectorant, Antitussive, Nasal Decongestant, Antihistamine, Pain reliever aid

INDICATIONS & USAGE

Uses temporarily relieves these common cold symptoms:

• runny nose & sneezing
• nasal congestion
• sore throat
• cough
• phlegm
• chills
• fever
• headache
• joint pain
• muscle pain

WARNINGS SECTION

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 glasses of alcohol everyday while using this product

Allergy alert: acetaminophen mat 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

Do not use

• if you ever had an allergic reaction to this product or any of its ingredients
• with any other drug containing acetaminophen. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• If you are 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 MAOI, ask a doctor or pharmacist before taking this product.
• If you are taking expectorants, other cold drugs, antipyretic-analgesics, sedatives, oral drugs containing antihistamines (oral drugs for rhinitis, motion sickness drugs, and allergy drugs)

ASK A DOCTOR

Ask a doctor before use if you have

• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarge prostate gland
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• cough that occurs with too much phlegm (mucus)
• glaucoma (eye pain, blurred vision)
• weak body
• high fever

STOP USE

Stop use and ask doctor if

• nervousness, dizziness, or sleeplessness occur
• pain, nasal congestion or cough gets worse or last more than 7 days
• fever gets worse or lasts more than 3 days n redness or swelling is present
• cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptom.

DOSAGE & ADMINISTRATION

Directions

• do not take more than directed (see overdose warning)

• Adults: Take 1 bottle (30mL) three times a day, 30 minutes after meal.
• Children and infants: Do not administer. Ask a doctor.

STORAGE AND HANDLING

Other nformation

• store at room temperature between 15°-25°C (59°-77°F) and avoid direct sunlight

INACTIVE INGREDIENTS

• Inactive Ingredients: : alcohol, citric acid monohydrate, edetate disodium, fructooligosaccharide, lemon flavor, orange flavor, propylene glycol, sodium citrate, sucralose, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PANCOLD A 
acetaminophen, guaifenesin, pentoxyverine citrate, phenylpehrine hydcrochloride, chlorpheniramine maleate, caffeine anhydrous liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51352-189
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	80 mg  in 30 mL
PENTOXYVERINE CITRATE (UNII: 4SH0MFJ5HJ) (PENTOXYVERINE - UNII:32C726X12W)	PENTOXYVERINE CITRATE	15 mg  in 30 mL
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	300 mg  in 30 mL
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2.5 mg  in 30 mL
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	30 mg  in 30 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)	32.4 mg  in 30 mL
SUCRALOSE (UNII: 96K6UQ3ZD4)	10 mg  in 30 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)	29 mg  in 30 mL
EDETATE DISODIUM (UNII: 7FLD91C86K)	3 mg  in 30 mL
ALCOHOL (UNII: 3K9958V90M)	0.5 mL  in 30 mL
SACCHARUM OFFICINARUM STEM FRUCTOOLIGOSACCHARIDES (UNII: 8LLD82AE3S)	7.5 g  in 30 mL
WATER (UNII: 059QF0KO0R)
ORANGE (UNII: 5EVU04N5QU)
LEMON (UNII: 24RS0A988O)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE (Light yellowish clear oral liquid with orange-lemon flavor.)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51352-189-73	3 in 1 CASE	07/01/2023
1		30 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 51352-189-75	5 in 1 CASE	12/07/2023	12/07/2023
2		30 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/01/2023

Labeler - DONGWHA PHARM. CO. LTD. (687745240)

Registrant - DONGWHA PHARM. CO. LTD. (687745240)

Establishment
Name	Address	ID/FEI	Business Operations
DONGWHA PHARM. CO., LTD.		687745240	manufacture(51352-189)