Label: COLD MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
- NDC Code(s): 30142-470-08
- Packager: Kroger Company
- 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.
Updated May 7, 2022
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- Active ingredients (in each caplet)
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
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
- 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)
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.
- more than 4,000 mg of acetaminophen in 24 hours
- Other information
- Inactive ingredients
- Questions or comments?
Principal Display Panel
COMPARE TO the active ingredients of TYLENOL® COLD MAX *See bottom panel
Pain Reliever/Fever Reducer
Fever, Sore Throat
OUR PHARMACIST RECOMMENDED
TAMPER EVIDENT: DO NOT USE IF PACKAGE IF OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*Tylenol® Cold Max is a registered trademark of Johnson & Johnson Corporation. New Brunswick, New Jersey 08933, Johnson & Johnson Corporation is not affiliated with The Kroger Co. or this product.
DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202
For More Product Information, Scan UPC
Using Your Kroger App or Call 800-632-6900
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INGREDIENTS AND APPEARANCE
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-470 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 (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:30142-470-08 2 in 1 CARTON 05/12/2021 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 final part341 05/12/2021 Labeler - Kroger Company (006999528) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(30142-470) , pack(30142-470) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(30142-470) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(30142-470)