COLD RELIEF MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Cold Relief by

Drug Labeling and Warnings

Cold Relief by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110, LLC. DBA Leader, LNK International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each caplet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant 

Uses

• temporarily relieves these common cold and flu symptoms:
  • minor aches and pains
  • headache
  • nasal congestion
  • cough
  • sore throat
  • sinus congestion and pressure
• temporarily reduces fever
• helps clear nasal passages
• promotes nasal and sinus drainage

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:

• blisters
• rash
• skin reddening

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.
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

• liver disease
• diabetes
• heart disease
• thyroid disease
• high blood pressure
• difficulty in urination due to enlargement of the prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus) 

Ask a doctor or pharmacist before use if you are

taking the blood thinning drug warfarin. 

When using this product

do not exceed recommended dosage.

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 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.

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
  
• adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
• children under 12 years: ask a doctor

Other information

• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• see end flap for expiration date and lot number 

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide 

Questions or comments?

1-800-426-9391

Principal Display Panel

LEADER™

NDC: 70000-0652-1
Multi-Symptom
Cold Relief

Acetaminophen | Dextromethorphan HBr | Phenylephrine HCl
Pain Reliever / Fever Reducer | Cough Suppressant | Nasal Decongestant

Pseudoephedrine Free
Temporarily Relieves: Headache, Fever,
Sore Throat, Cough, Nasal Congestion

24 CAPLETS with cool blast flavor
Actual Size
100% Money
Back Guarantee

All LEADER™ Brand
Products Have A
Money Back
100%
Guarantee

Return to place of
purchase if not satisfied.

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

50844 ORG072247008

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313

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

©2023 Cardinal Health. All Rights Reserved. CARDINAL
HEALTH, the Cardinal Health LOGO, LEADER, and the LEADER
LOGO are trademarks or registered trademarks of Cardinal
Health.

Leader 44-470

INGREDIENTS AND APPEARANCE

COLD RELIEF  MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0652
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	17mm
Flavor	MENTHOL	Imprint Code	44;470
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0652-1	2 in 1 CARTON	10/25/2023
1		12 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 Drug	M012	10/25/2023

Labeler - Cardinal Health 110, LLC. DBA Leader (063997360)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	manufacture(70000-0652) , pack(70000-0652, 70000-0652)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	manufacture(70000-0652, 70000-0652)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		117025878	manufacture(70000-0652)