Label: LEADER COLD RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
- NDC Code(s): 70000-0168-1
- Packager: Cardinal Health 110, LLC. dba Leader
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 17, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- thyroid disease
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- diabetes
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
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- nervousness, dizziness, or sleeplessness occur
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- pain, nasal congestion or cough gets worse or lasts more than 7 days
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts
These could be signs of a serious condition.
- Directions
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
Non-Drowsy | Daytime
Cold Relief
Acetaminophen | Dextromethorphan HBr | Phenylephrine HCl
Pain Reliever / Fever Reducer | Cough Suppressant | Nasal Decongestant
Headache, Fever, Sore Throat,
Nasal Congestion, Cough
For Adults
COMPARE TO TYLENOL® COLD MAX active ingredients
24 CAPLETS
Actual Size
100% Money Back Guarantee
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INGREDIENTS AND APPEARANCE
LEADER COLD RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0168 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARNAUBA WAX (UNII: R12CBM0EIZ) CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape CAPSULE (caplet) Size 17mm Flavor VANILLA ((menthol)) Imprint Code L371 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0168-1 12 in 1 CARTON 12/07/2016 1 2 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 final part341 12/07/2016 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)