Available Formats

• Active ingredient (in each caplet)

  Acetaminophen 325 mg

  Dextromethorphan HBr 10 mg

  Guaifenesin 200 mg

  Phenylephrine HCl 5 mg

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• Purpose

  Pain reliever/fever reducer

  Cough suppressant

  Expectorant

  Nasal decongestant

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• Uses

  • for the temporary relief of the following cold/flu symptoms:
  • minor aches and pains
  • headache
  • sore throat
  • nasal congestion
  • cough
  • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever

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• Warnings

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

  • more than 12 caplets 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

  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.

  Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis 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 use more than directed

  Stop use and ask a doctor if

  • you get nervous, dizzy or sleepless
  • 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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• Directions

  • do not take more than directed (see Liver warning)

  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 12 caplets in 24 hours
  children under 12 years	do not use this adult product in children under 12 years of age

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• Other information

  • each caplet contains: sodium 3 mg

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• Inactive ingredients

  acesulfame potassium, carnauba wax, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, silicon dioxide, stearic acid, talc, titanium dioxide

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• Questions or comments? 1-800-719-9260

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• Principal Display Panel

  Compare to the active ingredients in Tylenol® Cold Multi-Symptom Severe Cool Burst® Caplets

  SEVERE

  multi-symptom

  daytime cold relief

  fever/headache/sore throat (acetaminophen 325 mg)

  nasal congestion (phenylephrine HCl 5 mg)

  coughing (dextromethorphan HBr 10 mg)

  chest congestion (guaifenesin 200 mg)

  NON-DROWSY

  PSEUDOEPHEDRINE FREE

  pain reliever/fever reducer

  nasal decongestant

  cough suppressant

  expectorant

  ACTUAL SIZE

  SEE NEW WARNINGS INFORMATION

  COOL ICE®

  INSTANT COOLING SENSATION

  

  Daytime Cold Relief Carton Image 1

  

  Daytime Cold Relief Carton Image 2

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• INGREDIENTS AND APPEARANCE

  DAYTIME COLD RELIEF  MULTI SYMPTOM acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coated

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0308 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)   CARNAUBA WAX (UNII: R12CBM0EIZ)   CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)   CROSPOVIDONE (UNII: 68401960MK)   MALTODEXTRIN (UNII: 7CVR7L4A2D)   CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)   POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)   POLYVINYL ALCOHOL (UNII: 532B59J990)   POVIDONE (UNII: FZ989GH94E)   SILICON DIOXIDE (UNII: ETJ7Z6XBU4)   STEARIC ACID (UNII: 4ELV7Z65AP)   TALC (UNII: 7SEV7J4R1U)   TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

  Product Characteristics Color YELLOW Score no score Shape OVAL (capsule shaped) Size 20mm Flavor VANILLA (menthol) Imprint Code L234 Contains

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0308-1 2 in 1 CARTON 1 12 in 1 BLISTER PACK

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 10/22/2007

  Labeler - Rite Aid Corporation (014578892)

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