630t Rite Aid Cold And Flu Fast Dissolving

630t Rite Aid Cold And Flu Fast Dissolving
SPL v1
SPL
SPL Set ID ad2ab189-9672-3322-e053-2995a90ac9e5
Route
ORAL
Published
Effective Date 2020-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (200 mg) Acetaminophen (325 mg) Phenylephrine (5 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Gelatin Shellac Povidone Titanium Dioxide Fd&c Yellow No. 6 Propylene Glycol Water Polyethylene Glycol, Unspecified Glycerin Sorbitol Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Imprint: 72 Shape: capsule Color: orange Color: green Size: 10 mm Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-07-07
Description

Active ingredients (in each softgel) ACETAMINOPHEN 325MG DEXTROMETHORHAN HBR10 MG, GUAIFENESIN 200 MG , PHENYLEPHRINE HCL 5 MG

Medication Information

Warnings and Precautions

Warnings

Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
  • 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
  • Blisters
  • 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.

Indications and Usage
  • temporarily relieves common cold/flu symptoms: nasal congestion,headache, cough, minor aches and pains, sore throat
  • temoporarily reducces fever
  • prootes nasal and/or sinus drainage
  • helps ollsen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and Administration

Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period

  • adults & children 12 yrs & over 2 Softgels every 4 hrs
  • children 4 to under 12 yrs: Do not use

Description

Active ingredients (in each softgel) ACETAMINOPHEN 325MG DEXTROMETHORHAN HBR10 MG, GUAIFENESIN 200 MG , PHENYLEPHRINE HCL 5 MG

Section 50565-1

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 55105-1

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

CHEST CONGESTION

Section 55106-9

Active ingredients (in each softgel)

ACETAMINOPHEN 325MG

DEXTROMETHORHAN HBR10 MG,

GUAIFENESIN 200 MG

, PHENYLEPHRINE HCL 5 MG

Structured Label Content

Indications and Usage (34067-9)
  • temporarily relieves common cold/flu symptoms: nasal congestion,headache, cough, minor aches and pains, sore throat
  • temoporarily reducces fever
  • prootes nasal and/or sinus drainage
  • helps ollsen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage and Administration (34068-7)

Do not take more than directed (See Overdose warning section) - do not exceed 12 Softgels per 24 hr period

  • adults & children 12 yrs & over 2 Softgels every 4 hrs
  • children 4 to under 12 yrs: Do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels

This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product
  • 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
  • Blisters
  • 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage.

In case of overdose, get medical help or contact a Poison Control Center right away. (1800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PAIN RELIEVER-FEVER REDUCER

COUGH SUPPRESENT

MINOR ACHES AND PAINS

CHEST CONGESTION

Section 55106-9 (55106-9)

Active ingredients (in each softgel)

ACETAMINOPHEN 325MG

DEXTROMETHORHAN HBR10 MG,

GUAIFENESIN 200 MG

, PHENYLEPHRINE HCL 5 MG

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:30.189181 · Updated: 2026-03-14T22:58:05.187766