Cold Medicine by Allegiant Health COLD MEDICINE tablet

Cold Medicine by

Drug Labeling and Warnings

Cold Medicine by is a Otc medication manufactured, distributed, or labeled by Allegiant Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient(s)

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Use(s)

temporarily relieves

• minor aches and pains
• headaches
• nasal congestion
• sinus congestion & pressure
• runny nose
• sneezing
  

Warnings

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

• more than 10 tablets in 24 hours, which is the maximum daily amount
• 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.
  

Do not use

• if you are allergic to acetaminophen

• more than 10 days unless directed by a doctor

• 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

• with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

you have

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

Ask a doctor or pharmacist before use if

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

When using this product

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

Stop use and ask a doctor if

• redness or swelling is present
• new symptoms occur
• you get nervous, dizzy, or sleepless
• pain or nasal congestion gets worse or lasts for more than 7 days
• fever gets worse or lasts for more than 3 days
  

Pregnancy/Breastfeeding

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

Keep out of reach of children

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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 symptoms.

Directions

•  Do not use more than directed

• Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours
  Do not take more than 10 tablets in 24 hours
  

• Children under 12 years of age: do not use this product in children under 12 years
  of age; this will provide more than the recommended dose (overdose) and may cause
  liver damage.
  

Other information

• store at room temperature in a dry place
• do not use if blister package is torn.
  

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST.

Principal Display Panel

Cold Congestion

INGREDIENTS AND APPEARANCE

COLD MEDICINE 
cold medicine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 2S7830E561)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	AZ275
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-004-51	20 in 1 CARTON; Type 0: Not a Combination Product	11/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	11/12/2021

Labeler - Allegiant Health (079501930)