Label: COLD AND FLU SEVERE- acetaminophen,dextromethorphan hbr,guaifenesin,phenylephrine hcl tablet, film coated
- NDC Code(s): 49035-053-08, 49035-053-42
- Packager: Wal-Mart Stores Inc
- 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 June 14, 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
- heart disease
- liver disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- thyroid disease
- cough that occurs with too much phlegm (mucus)
- difficulty in urination due to enlargement of the prostate gland
- high blood pressure
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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Other information
- Inactive ingredients
- Questions or comments?
Principal display panel
COLD + FLU
Cold & Flu
Guaifenesin, Phenylephrine HCl
Pain Reliever/Fever Reducer,
Cough Suppressant, Expectorant,
• Headache, fever, sore throat
• Nasal congestion
• Chest congestion
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
Satisfaction guaranteed - Or we'll replace it or give you your
money back. For questions or comments or to report an
undesired reaction or side effect, please call 1-888-287-1915.
DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
*This product is not manufactured or distributed by Johnson & Johnson
Corporation, owner of the registered trademark Tylenol® COLD + FLU SEVERE.
INGREDIENTS AND APPEARANCE
COLD AND FLU SEVERE
acetaminophen,dextromethorphan hbr,guaifenesin,phenylephrine hcl tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-053 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color yellow Score no score Shape OVAL Size 19mm Flavor MENTHOL Imprint Code 44;503 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49035-053-08 2 in 1 CARTON 08/04/2005 1 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:49035-053-42 12 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/04/2005 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/04/2005 Labeler - Wal-Mart Stores Inc (051957769) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 pack(49035-053) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(49035-053)